Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-31 @ 5:46 AM
Study NCT ID:
NCT01603251
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077611', 'term': 'Artemether, Lumefantrine Drug Combination'}, {'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D000077549', 'term': 'Artemether'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000078102', 'term': 'Lumefantrine'}, {'id': 'D005449', 'term': 'Fluorenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '2012-05-16', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '8 days', 'description': 'The number of adverse events; number of participants with abnormal haemoglobin, biochemistry or full blood count values'}], 'secondaryOutcomes': [{'measure': 'Mosquitocidal activity', 'timeFrame': 'feeding experiments performed up to 8 days after enrolment; survival of mosquitoes determined up to day 10 after feeding', 'description': 'Daily mortality rates of (malaria-infected) Anopheles gambiae s.s. and An. funestus mosquitoes after taking a blood meal 1, 3 or 7 days after initiation of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transmission', 'anopheles'], 'conditions': ['Malaria']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asymptomatically infected individuals with any P. falciparum parasite density\n\nExclusion Criteria:\n\n* age \\< 15 years or \\> 25 years\n* malaria parasite density ≥ 10,000 parasites/µL\n* clinical symptoms indicating severe malaria\n* axillary temperature ≥ 37.5°C\n* Body Mass Index (BMI) below 18 or above 32 kg/m2\n* haemoglobin concentration below 11 g/dL\n* taken ivermectin in the last three months\n* Loa loa as assessed by questionnaire, clinical examination and parasitological assessments\n* for women: pregnancy or lactation\n* known hypersensitivity to AL or IVM\n* history and/or symptoms indicating chronic illness\n* current use of tuberculosis or anti-retroviral medication\n* unable to give written informed consent\n* unwillingness to participate in two membrane feeding assays\n* travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.\n* history of cardiovascular disease.\n* taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.\n* known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.\n* taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).'}, 'identificationModule': {'nctId': 'NCT01603251', 'acronym': 'ACTIVE', 'briefTitle': 'Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'A Double Blind Randomized Controlled Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission', 'orgStudyIdInfo': {'id': 'ACTIVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Artemether-Lumefantrine', 'interventionNames': ['Drug: Artemether-lumefantrine combination']}, {'type': 'EXPERIMENTAL', 'label': 'Artemether-Lumefantrine + single dose Ivermectin', 'interventionNames': ['Drug: Artemether-lumefantrine combination + single dose Ivermectin']}, {'type': 'EXPERIMENTAL', 'label': 'Artemether-Lumefantrine + repeated dose Ivermectin', 'interventionNames': ['Drug: Artemether-lumefantrine combination + repeated dose Ivermectin']}], 'interventions': [{'name': 'Artemether-lumefantrine combination', 'type': 'DRUG', 'description': 'Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL', 'armGroupLabels': ['Artemether-Lumefantrine']}, {'name': 'Artemether-lumefantrine combination + single dose Ivermectin', 'type': 'DRUG', 'description': 'Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given once together with the first dose of AL. A placebo is given together with the fifth dose of AL.', 'armGroupLabels': ['Artemether-Lumefantrine + single dose Ivermectin']}, {'name': 'Artemether-lumefantrine combination + repeated dose Ivermectin', 'type': 'DRUG', 'description': 'Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.', 'armGroupLabels': ['Artemether-Lumefantrine + repeated dose Ivermectin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Centre National de Recherche et de Formation sur le Paludisme', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}], 'overallOfficials': [{'name': 'Teun Bousema', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'Centre national de recherche et de formation sur le paludisme', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}