Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-04-05 @ 8:39 PM
Study NCT ID:
NCT00310505
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2006-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amphotericin B Treatment in Visceral Leishmaniasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007898', 'term': 'Leishmaniasis, Visceral'}], 'ancestors': [{'id': 'D007896', 'term': 'Leishmaniasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'lastUpdateSubmitDate': '2008-09-11', 'studyFirstSubmitDate': '2006-04-03', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final cure rate at six months after the end of treatment'}]}, 'conditionsModule': {'keywords': ['visceral leishmaniasis', 'amphotericin B', 'Kala-azar'], 'conditions': ['Visceral Leishmaniasis']}, 'referencesModule': {'references': [{'pmid': '17682988', 'type': 'DERIVED', 'citation': 'Sundar S, Chakravarty J, Rai VK, Agrawal N, Singh SP, Chauhan V, Murray HW. Amphotericin B treatment for Indian visceral leishmaniasis: response to 15 daily versus alternate-day infusions. Clin Infect Dis. 2007 Sep 1;45(5):556-61. doi: 10.1086/520665. Epub 2007 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.', 'detailedDescription': 'This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parasitologically proved kala-azar\n\nExclusion Criteria:\n\n* HIV positive serology'}, 'identificationModule': {'nctId': 'NCT00310505', 'briefTitle': 'Amphotericin B Treatment in Visceral Leishmaniasis', 'organization': {'class': 'OTHER', 'fullName': 'Banaras Hindu University'}, 'officialTitle': 'Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis', 'orgStudyIdInfo': {'id': 'SS01MZP03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amphotericin B deoxycholate given as daily administration', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '221005', 'city': 'Muzaffarpur', 'state': 'Bihar', 'country': 'India', 'facility': 'Kala-azar Medical Research Center', 'geoPoint': {'lat': 26.12259, 'lon': 85.39055}}], 'overallOfficials': [{'name': 'Shyam Sundar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banaras Hindu University', 'class': 'OTHER'}}}}