Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03605758
Status:
TERMINATED
Last Update Posted:
2023-11-30
First Post:
2018-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Strongyloides Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013322', 'term': 'Strongyloidiasis'}], 'ancestors': [{'id': 'D017196', 'term': 'Rhabditida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christina.coyle@einsteinmed.edu', 'phone': '718-430-3525', 'title': 'Dr. Christina Coyle', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months post-treatment', 'description': 'Serious adverse events and Adverse Events were not assessed in participants prior to randomization. One participant died prior to randomization and was stratified into a distinct pre-randomization arm/group.', 'eventGroups': [{'id': 'EG000', 'title': 'Ivermectin Administered on Two Consecutive Days (Days 1 and 2)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ivermectin Administered Two Weeks Apart (Days 1 and 14)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants Assessed for Events Prior to Randomization', 'description': 'One participant expired prior to randomization into study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin Administered on Two Consecutive Days (Days 1 and 2)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days'}, {'id': 'OG001', 'title': 'Ivermectin Administered Two Weeks Apart (Days 1 and 14)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart'}], 'timeFrame': '3-4 months post treatment', 'description': 'The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \\>0.3 OD (optical density) means positive for infection while \\<0.29 OD means negative (no infection).', 'reportingStatus': 'POSTED', 'populationDescription': 'Serology samples at 3-4 months post treatment were not collected/processed and therefore serology data is not available.'}, {'type': 'PRIMARY', 'title': 'Level of Strongyloides Serology as Measured by ELISA at 6-8 Months Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin Administered on Two Consecutive Days (Days 1 and 2)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days'}, {'id': 'OG001', 'title': 'Ivermectin Administered Two Weeks Apart (Days 1 and 14)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart'}], 'timeFrame': '6-8 months post treatment', 'description': 'The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \\>0.3 OD (optical density) means positive for infection while \\<0.29 OD means negative (no infection).', 'reportingStatus': 'POSTED', 'populationDescription': 'Serology samples at 6-8 months post treatment were not collected/processed and therefore serology data is not available.'}, {'type': 'PRIMARY', 'title': 'Level of Strongyloides Serology as Measured by ELISA at 9-12 Months Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ivermectin Administered on Two Consecutive Days (Days 1 and 2)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days'}, {'id': 'OG001', 'title': 'Ivermectin Administered Two Weeks Apart (Days 1 and 14)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart'}], 'timeFrame': '9-12 months post treatment', 'description': 'The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \\>0.3 OD (optical density) means positive for infection while \\<0.29 OD means negative (no infection).', 'reportingStatus': 'POSTED', 'populationDescription': 'Serology samples at 9-12 months post treatment were not collected/processed and therefore serology data is not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ivermectin Administered on Two Consecutive Days (Days 1 and 2)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days'}, {'id': 'FG001', 'title': 'Ivermectin Administered Two Weeks Apart (Days 1 and 14)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not complete all 3 scheduled visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}], 'recruitmentDetails': '51 participants consented. One participant expired before treatment, one participant was pregnant, and one participant was unable to be accounted for before treatment. As such, 48 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ivermectin Administered on Two Consecutive Days (Days 1 and 2)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given on two consecutive days'}, {'id': 'BG001', 'title': 'Ivermectin Administered Two Weeks Apart (Days 1 and 14)', 'description': 'Serologic response in patients with Strongyloides stercoralis infection after treatment with a regimen of two single doses of 200 μg/kg of ivermectin given 2 weeks apart'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Other, not specified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline demographic data was available for 48 of the 51 participants who consented.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'The original study PI passed away. Primary and Study Completion dates revised to reflect last participant examination date.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2015-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2018-07-23', 'resultsFirstSubmitDate': '2023-11-02', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-28', 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Strongyloides Serology as Measured by ELISA at 3-4 Months Post-treatment', 'timeFrame': '3-4 months post treatment', 'description': 'The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \\>0.3 OD (optical density) means positive for infection while \\<0.29 OD means negative (no infection).'}, {'measure': 'Level of Strongyloides Serology as Measured by ELISA at 6-8 Months Post-treatment', 'timeFrame': '6-8 months post treatment', 'description': 'The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \\>0.3 OD (optical density) means positive for infection while \\<0.29 OD means negative (no infection).'}, {'measure': 'Level of Strongyloides Serology as Measured by ELISA at 9-12 Months Post-treatment', 'timeFrame': '9-12 months post treatment', 'description': 'The level of Strongyloides serology as measured by Enzyme-linked immunosorbent assay (ELISA) indicates presence of infection. \\>0.3 OD (optical density) means positive for infection while \\<0.29 OD means negative (no infection).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Ivermectin', 'S. stercoralis', 'parasite', 'helminth', 'Filariform', 'larvae', 'Baermann technique'], 'conditions': ['Strongyloides Stercoralis Infection', 'Strongyloidiasis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the serologic response in patients with S. stercoralis infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given 2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two consecutive days.', 'detailedDescription': 'Patients will be randomly assigned to receive 2 single doses of ivermectin at 200 µg/kg 2 weeks apart versus ivermectin at 200 µg/kg for 2 consecutive days. Patients will be randomized 50-50 to the study groups using the date of birth and a random number table. All patients will be interviewed to obtain the medical history during the initial evaluation. Patients will be asked about demographic data on a questionnaire written in English and Spanish. Physical exams, baseline blood cell counts, serum chemistries, HTLV-1(human T-cell lymphotrophic virus) serology, an IgE (immunoglobulin E), a stool sample for O \\&P, and a pregnancy test will be performed as routine care all patients currently receive in our clinic.Procedures: Strongyloides serology will be performed in the parasitology laboratory of Jacobi Hospital with an in-house ELISA that uses a 31-kDA(kilodalton) recombinant protein antigen (termed NIE) derived from L3 stage of S. stercoralis and purified from E. coli BL21 containing pET30b plasmid. Once the in-house serology is performed serum will be banked, so it can be available to run in paired with samples taken during follow up visits. Blood samples will be also collected and sent to the Laboratory of Parasitic Diseases (LPD) at the NIAID- National Institutes of Health (NIH) to perform other serological techniques including the Luciferase Immunoprecipitation Systems Assay (LIPS) based on NIE and the recombinant antigen S. stercoralis immunoreactive antigen (SsIR). In addition, stools will be collected from all patients and will be fixated in SAF(sodium acetate, acetic acid and formalin), to check for Strongyloides stercoralis larvae. If possible, fresh stool will be obtained to check for larvae using the Baermann technique and an aliquot will be frozen and sent to the NIH for DNA extraction and PCR(polymerase chain reaction as).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Positive for Strongyloides serology infection (as determined by ELISA)\n\nExclusion Criteria:\n\n* Severe intestinal Strongyloides infection\n* Disseminated Strongyloidiasis infection\n* Pregnant and breastfeeding women\n* HTLV-1 co-infection\n* Patients with indeterminate results on Strongyloides serology\n* Patients who are immunosuppressed\n* Unable to read and understand consent form'}, 'identificationModule': {'nctId': 'NCT03605758', 'acronym': 'TSSI', 'briefTitle': 'Treatment of Strongyloides Infection', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'A Comparative Study of Two Regimens of Ivermectin for the Treatment of Strongyloides Stercoralis Infection', 'orgStudyIdInfo': {'id': '2012-233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ivermectin on Days 1 and 2', 'description': 'Participants will receive 200 µg/kg of ivermectin daily for two consecutive days with breakfast.', 'interventionNames': ['Drug: Ivermectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ivermectin on Days 1 and 14', 'description': 'Participants will receive 200 µg/kg of ivermectin on day one and day 14 with breakfast.', 'interventionNames': ['Drug: Ivermectin']}], 'interventions': [{'name': 'Ivermectin', 'type': 'DRUG', 'otherNames': ['Stromectol'], 'description': 'Ivermectin is an anti-parasitic', 'armGroupLabels': ['Ivermectin on Days 1 and 14', 'Ivermectin on Days 1 and 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Christina M Coyle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}