Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:20 PM
Study NCT ID:
NCT03527732
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of IVM/ALB Co-administration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014257', 'term': 'Trichuriasis'}], 'ancestors': [{'id': 'D017189', 'term': 'Enoplida Infections'}, {'id': 'D017188', 'term': 'Adenophorea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}, {'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.keiser@swisstph.ch', 'phone': '+41 (61) 284 8218', 'title': 'Prof. Dr. Jennifer Keiser', 'organization': 'Swiss Tropical and Public Health Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed 3h and 24h post treatment.', 'description': 'Adverse events were examined through standard questionnaires, graded into mild, moderate and severe (using Common Toxicity Criteria version 2.0 put forth by the Cancer Therapy Evaluation Program) and study physicians were asked to classify relatedness with drug administration in the most common expected adverse events. If causality could not be ruled out by other conditions or reasons, the adverse events were considered as possibly related.', 'eventGroups': [{'id': 'EG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire", 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 83, 'seriousNumAtRisk': 254, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire", 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 99, 'seriousNumAtRisk': 254, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 77, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 273, 'otherNumAffected': 72, 'seriousNumAtRisk': 273, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island', 'otherNumAtRisk': 305, 'deathsNumAtRisk': 305, 'otherNumAffected': 28, 'seriousNumAtRisk': 305, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 18, 'seriousNumAtRisk': 308, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 32, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'notes': 'allergy-like syndromes including rash, itching and potentially also involving digestive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': 'Fever was defined as body temperature of 38°C and above.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 57, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 63, 'numAffected': 52}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 47, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 254, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 273, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 273, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 305, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '293', 'groupId': 'OG004'}, {'value': '288', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'OG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}], 'classes': [{'categories': [{'title': 'Cured', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '140', 'groupId': 'OG005'}]}, {'title': 'Not cured', 'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '275', 'groupId': 'OG004'}, {'value': '148', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14-21 days after treatment', 'description': 'The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG001', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG002', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'OG003', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}], 'classes': [{'title': 'Cured at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}, {'value': '276', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Cured at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 12 months after treatment', 'description': 'Conversion of T. trichiura egg-positive participants at baseline who become egg-negative 6 and 12 months after treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis set of all randomized participants who provided any follow-up data at 6 or 12 months post treatment was used to perform an available-case analysis.'}, {'type': 'SECONDARY', 'title': 'Egg-reduction Rate (ERR) Against T. Trichiura', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '293', 'groupId': 'OG004'}, {'value': '288', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'OG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}], 'classes': [{'title': 'Geometric mean ERR at 14-21 days post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '213', 'groupId': 'OG003'}, {'value': '293', 'groupId': 'OG004'}, {'value': '288', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '72'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '61', 'upperLimit': '77'}, {'value': '69', 'groupId': 'OG002', 'lowerLimit': '61', 'upperLimit': '75'}, {'value': '99', 'groupId': 'OG003', 'lowerLimit': '99', 'upperLimit': '99'}, {'value': '57', 'groupId': 'OG004', 'lowerLimit': '48', 'upperLimit': '65'}, {'value': '98', 'groupId': 'OG005', 'lowerLimit': '98', 'upperLimit': '99'}]}]}, {'title': 'Geometric mean ERR at 6 months post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG002', 'lowerLimit': '73.8', 'upperLimit': '84.3'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '98.6', 'upperLimit': '99.3'}, {'value': '21.2', 'groupId': 'OG004', 'lowerLimit': '8.1', 'upperLimit': '33.0'}, {'value': '84.9', 'groupId': 'OG005', 'lowerLimit': '80.7', 'upperLimit': '88.2'}]}]}, {'title': 'Geometric mean ERR at 12 months post treatmentpost treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '264', 'groupId': 'OG004'}, {'value': '251', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG002', 'lowerLimit': '88.5', 'upperLimit': '93.5'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '99.4', 'upperLimit': '99.7'}, {'value': '53.6', 'groupId': 'OG004', 'lowerLimit': '45.4', 'upperLimit': '60.9'}, {'value': '92.9', 'groupId': 'OG005', 'lowerLimit': '91.0', 'upperLimit': '94.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '14-21 days, 6 months and 12 months after treatment', 'description': 'Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.', 'unitOfMeasure': 'percent of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed corresponds to all participants that got randomized. An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis for each assessment time point (i.e., 14-21 days, 6 months and 12 months post-treatment).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'OG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}], 'classes': [{'title': 'Cured from Ascaris lumbricoides at 14-21 d post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '86', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '85', 'groupId': 'OG005'}]}]}, {'title': 'Egg negative for Ascaris lumbricoides 6 months post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}, {'value': '205', 'groupId': 'OG004'}, {'value': '215', 'groupId': 'OG005'}]}]}, {'title': 'Egg negative for Ascaris lumbricoides 12 months post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '264', 'groupId': 'OG004'}, {'value': '251', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}]}, {'title': 'Cured from hookworm 14-21 d post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}]}, {'title': 'Egg negative for hookworm 6 months post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '262', 'groupId': 'OG004'}, {'value': '262', 'groupId': 'OG005'}]}]}, {'title': 'Egg negative for hookworm 12 months post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '264', 'groupId': 'OG004'}, {'value': '251', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '250', 'groupId': 'OG004'}, {'value': '231', 'groupId': 'OG005'}]}]}, {'title': 'Cured from Strongyloides stercoralis 14-21 d post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14-21 days, 6 months and 12 months after treatment', 'description': 'Number of participants that converted from egg positive with Ascaris lumbricoides, hookworm and/or Strongyloides stercoralis infections to egg negative after 14-21 days. Number of egg-negatives at 6 and 12 months after treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants include all randomized participants. To assess the number of cured 14-21 days post-treatment only randomized baseline egg positive participants with follow-up stool data were considered. For the 6 and 12 month assessment all randomized participants with at least one stool sample analyzed were considered. The number cured as assessed 14-21 days post-treatment provides a proportion that is considered the cure rate (conversion rate from positive to negative).'}, {'type': 'SECONDARY', 'title': 'Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'OG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'OG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'OG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}], 'classes': [{'title': 'ERRs in A. lumbricoides co-infected 14-21 days post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '86', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG003', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG005', 'lowerLimit': '100', 'upperLimit': '100'}]}]}, {'title': 'Extended ERRs for A. lumbricoides 6 month post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG002', 'lowerLimit': '66.1', 'upperLimit': '90.9'}, {'value': '75.8', 'groupId': 'OG003', 'lowerLimit': '54.1', 'upperLimit': '87.4'}, {'value': '-5.7', 'groupId': 'OG004', 'lowerLimit': '-76.6', 'upperLimit': '37.7'}, {'value': '47.4', 'groupId': 'OG005', 'lowerLimit': '6.1', 'upperLimit': '69.5'}]}]}, {'title': 'Extended ERRs for A. lumbricoides 12 month post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '264', 'groupId': 'OG004'}, {'value': '251', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG002', 'lowerLimit': '73.6', 'upperLimit': '94.0'}, {'value': '77.0', 'groupId': 'OG003', 'lowerLimit': '52.3', 'upperLimit': '89.0'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '-36.2', 'upperLimit': '58.6'}, {'value': '48.0', 'groupId': 'OG005', 'lowerLimit': '5.1', 'upperLimit': '70.9'}]}]}, {'title': 'ERRs in hookworm co-infected 14-21 days post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG002', 'lowerLimit': '98', 'upperLimit': '99'}, {'value': '99', 'groupId': 'OG003', 'lowerLimit': '99', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG004', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '97', 'groupId': 'OG005', 'lowerLimit': '93', 'upperLimit': '99'}]}]}, {'title': 'Extended ERRs for hookworm 6 month post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '234', 'groupId': 'OG003'}, {'value': '282', 'groupId': 'OG004'}, {'value': '276', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '94.9', 'upperLimit': '97.7'}, {'value': '97.7', 'groupId': 'OG003', 'lowerLimit': '96.4', 'upperLimit': '98.4'}, {'value': '72.2', 'groupId': 'OG004', 'lowerLimit': '56.3', 'upperLimit': '84.1'}, {'value': '73.2', 'groupId': 'OG005', 'lowerLimit': '58.1', 'upperLimit': '86.1'}]}]}, {'title': 'Extended ERRs for hookworm 12 month post treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '264', 'groupId': 'OG004'}, {'value': '251', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG002', 'lowerLimit': '98.1', 'upperLimit': '99.2'}, {'value': '99.2', 'groupId': 'OG003', 'lowerLimit': '98.7', 'upperLimit': '99.5'}, {'value': '74.5', 'groupId': 'OG004', 'lowerLimit': '57.5', 'upperLimit': '87.0'}, {'value': '59.2', 'groupId': 'OG005', 'lowerLimit': '40.2', 'upperLimit': '74.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '14-21 days, 6 months and 12 months after treatment', 'description': 'Percent change in geometric mean eggs per gram of stool from before to after treatment. ERRs will be calculated for Ascaris lumbricoides and hookworm infections as described in outcome 3.', 'unitOfMeasure': 'percent of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'An analysis set of all randomized participants who provided any follow-up data (14-21 days, 6 or 12 months post treatment) was used to perform an available-case analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'FG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'FG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'FG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'FG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'FG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '255'}, {'groupId': 'FG002', 'numSubjects': '274'}, {'groupId': 'FG003', 'numSubjects': '275'}, {'groupId': 'FG004', 'numSubjects': '305'}, {'groupId': 'FG005', 'numSubjects': '308'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '232'}, {'groupId': 'FG002', 'numSubjects': '194'}, {'groupId': 'FG003', 'numSubjects': '213'}, {'groupId': 'FG004', 'numSubjects': '293'}, {'groupId': 'FG005', 'numSubjects': '288'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '62'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '20'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': "Albendazole in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'BG001', 'title': "Albendazole and Ivermectin in Côte d'Ivoire", 'description': "400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Côte d'Ivoire"}, {'id': 'BG002', 'title': 'Albendazole in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'BG003', 'title': 'Albendazole and Ivermectin in Laos', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Laos'}, {'id': 'BG004', 'title': 'Albendazole in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and placebo tablets (corresponding number to ivermectin weight-dependent dosing) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'BG005', 'title': 'Albendazole and Ivermectin in Pemba Island', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally to community members aged 6-60 years in Pemba Island'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '16.0', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '27.7', 'spread': '17.3', 'groupId': 'BG002'}, {'value': '25.9', 'spread': '17.4', 'groupId': 'BG003'}, {'value': '14.0', 'spread': '10.5', 'groupId': 'BG004'}, {'value': '13.9', 'spread': '9.6', 'groupId': 'BG005'}, {'value': '18.9', 'spread': '15.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'School-aged (6-12 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '191', 'groupId': 'BG004'}, {'value': '184', 'groupId': 'BG005'}, {'value': '919', 'groupId': 'BG006'}]}]}, {'title': 'Youth or young people (13-24 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}, {'value': '304', 'groupId': 'BG006'}]}]}, {'title': 'Adults (25-60 years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '450', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}, {'value': '169', 'groupId': 'BG005'}, {'value': '880', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}, {'value': '139', 'groupId': 'BG005'}, {'value': '793', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '37.5', 'spread': '20.1', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '19.7', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '14.5', 'groupId': 'BG002'}, {'value': '39.7', 'spread': '15.7', 'groupId': 'BG003'}, {'value': '34.2', 'spread': '15.5', 'groupId': 'BG004'}, {'value': '34.0', 'spread': '14.8', 'groupId': 'BG005'}, {'value': '37.2', 'spread': '16.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1672', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '136.7', 'spread': '20.3', 'groupId': 'BG000'}, {'value': '135.8', 'spread': '19.4', 'groupId': 'BG001'}, {'value': '144.3', 'spread': '16.6', 'groupId': 'BG002'}, {'value': '142.3', 'spread': '16.7', 'groupId': 'BG003'}, {'value': '137.3', 'spread': '18.6', 'groupId': 'BG004'}, {'value': '137.7', 'spread': '18.9', 'groupId': 'BG005'}, {'value': '139.0', 'spread': '18.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One individual value from the Albendazole group in Laos omitted due to irrational value (479 cm).'}, {'title': 'T. trichiura geometric mean egg counts', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '481', 'groupId': 'BG000', 'lowerLimit': '192', 'upperLimit': '1040'}, {'value': '470', 'groupId': 'BG001', 'lowerLimit': '174', 'upperLimit': '954'}, {'value': '366', 'groupId': 'BG002', 'lowerLimit': '174', 'upperLimit': '678'}, {'value': '349', 'groupId': 'BG003', 'lowerLimit': '168', 'upperLimit': '618'}, {'value': '467', 'groupId': 'BG004', 'lowerLimit': '198', 'upperLimit': '894'}, {'value': '461', 'groupId': 'BG005', 'lowerLimit': '198', 'upperLimit': '955'}, {'value': '429', 'groupId': 'BG006', 'lowerLimit': '186', 'upperLimit': '846'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'Eggs per gram of stool', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'T. trichiura infection intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}, {'value': '308', 'groupId': 'BG005'}, {'value': '1673', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Light (1-999 EPG)', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}, {'value': '234', 'groupId': 'BG005'}, {'value': '1311', 'groupId': 'BG006'}]}, {'title': 'Moderate (1000-9999 EPG)', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '353', 'groupId': 'BG006'}]}, {'title': 'heavy (≥10 000 EPG)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'A. lumbricoides geometric mean egg counts', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}, {'value': '554', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '5499', 'groupId': 'BG000', 'lowerLimit': '1020', 'upperLimit': '24744'}, {'value': '4130', 'groupId': 'BG001', 'lowerLimit': '1104', 'upperLimit': '26022'}, {'value': '3991', 'groupId': 'BG002', 'lowerLimit': '1161', 'upperLimit': '18315'}, {'value': '3635', 'groupId': 'BG003', 'lowerLimit': '1389', 'upperLimit': '12435'}, {'value': '4515', 'groupId': 'BG004', 'lowerLimit': '1938', 'upperLimit': '11892'}, {'value': '2979', 'groupId': 'BG005', 'lowerLimit': '1272', 'upperLimit': '8652'}, {'value': '4036', 'groupId': 'BG006', 'lowerLimit': '1284', 'upperLimit': '15690'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'Eggs per gram of stool', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Only A. lumbricoides co-infected participants considered.'}, {'title': 'A. lumbricoides infection intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}, {'value': '554', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Light (1-4999 EPG)', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '273', 'groupId': 'BG006'}]}, {'title': 'Moderate (5000-49 999 EPG)', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}, {'value': '245', 'groupId': 'BG006'}]}, {'title': 'Heavy (≥50 000 EPG)', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only A. lumbricoides co-infected participants considered.'}, {'title': 'Hookworm geometric mean egg counts', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '647', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '240'}, {'value': '91', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '186'}, {'value': '805', 'groupId': 'BG002', 'lowerLimit': '390', 'upperLimit': '2172'}, {'value': '840', 'groupId': 'BG003', 'lowerLimit': '348', 'upperLimit': '2202'}, {'value': '100', 'groupId': 'BG004', 'lowerLimit': '36', 'upperLimit': '294'}, {'value': '80', 'groupId': 'BG005', 'lowerLimit': '24', 'upperLimit': '210'}, {'value': '501', 'groupId': 'BG006', 'lowerLimit': '168', 'upperLimit': '1692'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'Eggs per gram of stool', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Only hookworm co-infected participants considered.'}, {'title': 'Hookworm infection intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '647', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Light (1-1999 EPG)', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '508', 'groupId': 'BG006'}]}, {'title': 'Moderate (2000-3999 EPG)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}, {'title': 'Heavy (≥4000 EPG)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only hookworm co-infected participants considered.'}, {'title': 'S. stercoralis infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '274', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '547', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baermann technique to detect S. stercoralis infection was applied only to stool samples collected in Laos; two participants (one in each group) had no S. stercoralis result.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-24', 'size': 3910982, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-24T04:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The parallel group trial will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using repacked tablets including appearance-matched placebos while the dose-finding study will be single blinded (i.e. all outcome assessors except the investigators who provide the treatment and the study participants who get either active or placebo tablets matching in appearance will be blinded) due to the nature of this study (i.e. including ascending doses).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1673}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2018-05-03', 'resultsFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-31', 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)', 'timeFrame': '14-21 days after treatment', 'description': 'The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment', 'timeFrame': '6 and 12 months after treatment', 'description': 'Conversion of T. trichiura egg-positive participants at baseline who become egg-negative 6 and 12 months after treatment.'}, {'measure': 'Egg-reduction Rate (ERR) Against T. Trichiura', 'timeFrame': '14-21 days, 6 months and 12 months after treatment', 'description': 'Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.'}, {'measure': 'Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)', 'timeFrame': '14-21 days, 6 months and 12 months after treatment', 'description': 'Number of participants that converted from egg positive with Ascaris lumbricoides, hookworm and/or Strongyloides stercoralis infections to egg negative after 14-21 days. Number of egg-negatives at 6 and 12 months after treatment.'}, {'measure': 'Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections.', 'timeFrame': '14-21 days, 6 months and 12 months after treatment', 'description': 'Percent change in geometric mean eggs per gram of stool from before to after treatment. ERRs will be calculated for Ascaris lumbricoides and hookworm infections as described in outcome 3.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trichuriasis']}, 'referencesModule': {'references': [{'pmid': '38517907', 'type': 'DERIVED', 'citation': 'Welsche S, Schneeberger PHH, Hattendorf J, Sayasone S, Hurlimann E, Keiser J. Egg excretion patterns of soil-transmitted helminth infections in humans following albendazole-ivermectin and albendazole treatment. PLoS Negl Trop Dis. 2024 Mar 22;18(3):e0012073. doi: 10.1371/journal.pntd.0012073. eCollection 2024 Mar.'}, {'pmid': '35217670', 'type': 'DERIVED', 'citation': 'Schneeberger PHH, Gueuning M, Welsche S, Hurlimann E, Dommann J, Haberli C, Frey JE, Sayasone S, Keiser J. Different gut microbial communities correlate with efficacy of albendazole-ivermectin against soil-transmitted helminthiases. Nat Commun. 2022 Feb 25;13(1):1063. doi: 10.1038/s41467-022-28658-1.'}, {'pmid': '34856181', 'type': 'DERIVED', 'citation': "Hurlimann E, Keller L, Patel C, Welsche S, Hattendorf J, Ali SM, Ame SM, Sayasone S, Coulibaly JT, Keiser J. Efficacy and safety of co-administered ivermectin and albendazole in school-aged children and adults infected with Trichuris trichiura in Cote d'Ivoire, Laos, and Pemba Island, Tanzania: a double-blind, parallel-group, phase 3, randomised controlled trial. Lancet Infect Dis. 2022 Jan;22(1):123-135. doi: 10.1016/S1473-3099(21)00421-7. Epub 2021 Nov 29."}, {'pmid': '34191812', 'type': 'DERIVED', 'citation': 'Keller L, Welsche S, Patel C, Sayasone S, Ali SM, Ame SM, Hattendorf J, Hurlimann E, Keiser J. Long-term outcomes of ivermectin-albendazole versus albendazole alone against soil-transmitted helminths: Results from randomized controlled trials in Lao PDR and Pemba Island, Tanzania. PLoS Negl Trop Dis. 2021 Jun 30;15(6):e0009561. doi: 10.1371/journal.pntd.0009561. eCollection 2021 Jun.'}, {'pmid': '30885157', 'type': 'DERIVED', 'citation': 'Patel C, Hurlimann E, Keller L, Hattendorf J, Sayasone S, Ali SM, Ame SM, Coulibaly JT, Keiser J. Efficacy and safety of ivermectin and albendazole co-administration in school-aged children and adults infected with Trichuris trichiura: study protocol for a multi-country randomized controlled double-blind trial. BMC Infect Dis. 2019 Mar 18;19(1):262. doi: 10.1186/s12879-019-3882-x.'}]}, 'descriptionModule': {'briefSummary': "This study is a double-blind randomized clinical trial conducted with two settings in Africa and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in children and adults (6-60 years).\n\nThe efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. The cure rate will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment.", 'detailedDescription': 'This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against T. trichiura infections in children and adults (6-60 years) in different transmission settings and geographies. Embedded in this trial a smaller dose-finding (DF) study with the goal to investigate efficacy, safety and pharmacokinetic parameters of ascending doses of ivermectin ((i) 200 µg/kg, (ii) 400 µg/kg, and (iii) 600 µg/kg) co-administered with albendazole (400 mg) in school-aged children infected with T. trichiura will take place.\n\nThe primary objective of the trial is to comparatively assess the efficacy in terms of cure rate against T. trichiura infections among school-aged children and adults from three different epidemiological settings and monitored over a 12-month period of albendazole/ivermectin combination therapy and albendazole monotherapy. A DF study will be implemented in the trial with the objective to understand the dose-dependent efficacy and pharmacokinetic profile of the co-administration of albendazole and ivermectin in school-aged children (6-12 years) with the following four oral treatment regimens: i) albendazole (400 mg) /ivermectin (200 µg/kg) combination, ii) albendazole (400 mg) /ivermectin (400 µg/kg) combination, iii) albendazole (400 mg) /ivermectin (600 µg/kg) combination, and iv) placebo.\n\nThe secondary objectives of the trial are to evaluate the safety and tolerability of the treatment regimens, compare the ERRs of the treatment regimens (combination vs. monotherapy and ascending doses of the combination) against T. trichiura, determine the CRs and ERRs of the drugs in study participants (6-60 years) infected with hookworm, A lumbricoides and S stercoralis, investigate potential extended effects on follow-up helminth prevalences (6 and 12 months post-treatment) of the two standard-dose treatment regimens (as assessed among participants with cleared infection on days 21 and 180), compare CRs based on infection status determined by novel polymerase chain reaction (PCR)-based and standard microscopic diagnosis, assess potential differences in susceptibility to the treatment regimen between the three hookworm species, Necator americanus, Ancylostoma duodenale and A. ceylanicum, as classified through the novel PCR-based diagnosis, characterize T. trichiura strains from different epidemiological settings through genotyping, evaluate potential benefits from deworming on morbidity (clinically evaluated and self-rated from questionnaire interviews) and nutritional indicators, and determine an exposure (including length of time that the drug concentration is above the minimal inhibitory concentration (MIC), Cmax, area under the curve (AUC))-response correlation of ivermectin and albendazole in school-aged children.\n\nAfter obtaining informed consent from individual/parents and/or caregiver, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.\n\nRandomization of participants into the two treatment arms will be stratified according to intensity of infection. All participants will be interviewed before treatment, 3 and 24 hours and 3 weeks after treatment about the occurrence of adverse events. Children aged 6-16 years will additionally be asked to rate their own physical functioning by replying to a pre-tested questionnaire at baseline and 6 and 12 months after treatment. The efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. Subjective treatment satisfaction will be assessed 3 hours, 3 weeks and 6 months after treatment to investigate relationship with treatment compliance and observed efficacy in reducing egg output and morbidity.\n\nThe primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment. Differences among CRs (between treatment arms and between diagnostic approaches) will be analysed by using crude and adjusted logistic regression modeling (adjustment for age, sex and weight).\n\nGeometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent signed by either the participant him/herself (≥21 years of age) or by parents and/or caregivers for children/adolescents; and written assent by child/adolescent (aged 6-20 years).\n2. Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (approximately 3 weeks, 6 months, and 12 months later).\n3. Aged ≥6 to \\<= 60 years for parallel group trial and ≥6 to \\<=12 years for DF study.\n4. At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 100 EPG.\n\nExclusion Criteria:\n\n1. No written informed consent by individual/parents and/or caregiver.\n2. Presence of major systemic illnesses, e.g. severe anemia (below 80 g/l Hb according to WHO \\[28\\]), clinical malaria as assessed by a medical doctor (positive Plasmodium RDT and ≥38 °C ear temperature), upon initial clinical assessment.\n3. History of acute or severe chronic disease (e.g. cancer, diabetes, chronic heart, liver or renal disease).\n4. Recent use of anthelmintic drug (within past 4 weeks).\n5. Attending other clinical trials during the study.\n6. Negative or low egg count (less than 100 EPG or less than 2 out of 4 slides positive) diagnostic result for T. trichiura eggs in the stool.\n7. Known allergy to study medications (i.e. albendazole and ivermectin).\n8. Pregnancy or lactating in the 1st week after birth (according to WHO guidelines within LF control programs \\[29\\]).\n9. Currently taking medication with known interaction (e.g. for albendazole: cimetidine, praziquantel and dexamethasone; for ivermectin: warfarin).'}, 'identificationModule': {'nctId': 'NCT03527732', 'briefTitle': 'Efficacy and Safety of IVM/ALB Co-administration', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': 'Efficacy and Safety of Ivermectin and Albendazole Co-administration in School-aged Children and Adults Infected With Trichuris Trichiura: a Multi-country Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm A: albendazole', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of placebo at day 0 administered orally', 'interventionNames': ['Drug: Albendazole']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: albendazole and ivermectin', 'description': '400 mg albendazole single tablet (Zentel®) and 200µg/kg using 3mg tablets of ivermectin (Stromectol®) at day 0 administered orally', 'interventionNames': ['Drug: Albendazole and Ivermectin']}], 'interventions': [{'name': 'Albendazole', 'type': 'DRUG', 'otherNames': ['Zentel®'], 'description': 'Monotherapy of albendazole (400 mg)', 'armGroupLabels': ['Arm A: albendazole']}, {'name': 'Albendazole and Ivermectin', 'type': 'DRUG', 'otherNames': ['Zentel® and Stromectol®'], 'description': 'Combination therapy of albendazole (400 mg) and ivermectin (200 µg/kg)', 'armGroupLabels': ['Arm B: albendazole and ivermectin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': "Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)", 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Vientiane', 'country': 'Laos', 'facility': 'Lao Tropical and Public Health Institute', 'geoPoint': {'lat': 17.96667, 'lon': 102.6}}, {'city': 'Chake Chake', 'state': 'Pemba', 'country': 'Tanzania', 'facility': 'Public Health Laboratory Ivo de Carneri, P.O. Box 122', 'geoPoint': {'lat': -5.24586, 'lon': 39.76659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Keiser', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre Suisse de Recherches Scientifiques en Cote d'Ivoire", 'class': 'OTHER'}, {'name': 'Lao Tropical and Public Health Institute', 'class': 'OTHER_GOV'}, {'name': 'Public Health Laboratory of Pemba, Tanzania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Jennifer Keiser, PhD', 'investigatorFullName': 'Jennifer Keiser', 'investigatorAffiliation': 'Swiss Tropical & Public Health Institute'}}}}