Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02176057
Status:
WITHDRAWN
Last Update Posted:
2015-05-21
First Post:
2014-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nepal Elimination of Trachoma Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014141', 'term': 'Trachoma'}], 'ancestors': [{'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}, {'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Nepal Ministry of Health implemented public drug treatment prior to the proposed start date', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trachoma (clinical and C. trachomatis)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Anthropometry (height for weight)', 'timeFrame': '12 months'}, {'measure': 'Malaria', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['trachoma'], 'conditions': ['Trachoma']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.\n\n1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \\<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.\n2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \\<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.\n\n2\\. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).', 'detailedDescription': 'Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1-9 years\n* Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal\n\nExclusion Criteria:\n\n* All individuals who are allergic to macrolides\n* All pregnant woman\n* All neonates'}, 'identificationModule': {'nctId': 'NCT02176057', 'acronym': 'NETS', 'briefTitle': 'Nepal Elimination of Trachoma Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Nepal Elimination of Trachoma Study', 'orgStudyIdInfo': {'id': 'NETS-13-10961'}, 'secondaryIdInfos': [{'id': 'K23EY019881', 'link': 'https://reporter.nih.gov/quickSearch/K23EY019881', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotic', 'description': 'Azithromycin, suspension (liquid), 1 gram, one-time dose', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'NO_INTERVENTION', 'label': 'Observation'}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax'], 'armGroupLabels': ['Antibiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10900', 'city': 'Geta', 'state': 'Kailali', 'country': 'Nepal', 'facility': 'Geta Eye Hospital', 'geoPoint': {'lat': 28.77396, 'lon': 80.56432}}], 'overallOfficials': [{'name': 'Bruce D Gaynor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF F. I. Proctor Foundation (California, USA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}