Back to resultsAmphotericin B Treatment in Visceral Leishmaniasis
Primary Purpose
Visceral Leishmaniasis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Amphotericin B deoxycholate given as daily administration
Sponsored by
About this trial
This is an interventional treatment trial for Visceral Leishmaniasis focused on measuring visceral leishmaniasis, amphotericin B, Kala-azar
Eligibility Criteria
Inclusion Criteria: Parasitologically proved kala-azar Exclusion Criteria: HIV positive serology
Sites / Locations
- Kala-azar Medical Research Center
Outcomes
Primary Outcome Measures
Final cure rate at six months after the end of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00310505
First Posted
April 3, 2006
Last Updated
September 11, 2008
Sponsor
Banaras Hindu University
1. Study Identification
Unique Protocol Identification Number
NCT00310505
Brief Title
Amphotericin B Treatment in Visceral Leishmaniasis
Official Title
Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Banaras Hindu University
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visceral Leishmaniasis
Keywords
visceral leishmaniasis, amphotericin B, Kala-azar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amphotericin B deoxycholate given as daily administration
Primary Outcome Measure Information:
Title
Final cure rate at six months after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parasitologically proved kala-azar
Exclusion Criteria:
HIV positive serology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyam Sundar, MD
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kala-azar Medical Research Center
City
Muzaffarpur
State/Province
Bihar
ZIP/Postal Code
221005
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
17682988
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.
Results Reference
derived
Learn more about this trial
Amphotericin B Treatment in Visceral Leishmaniasis
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