- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310505
Amphotericin B Treatment in Visceral Leishmaniasis
September 11, 2008 updated by: Banaras Hindu University
Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
1500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bihar
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Muzaffarpur, Bihar, India, 221005
- Kala-azar Medical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parasitologically proved kala-azar
Exclusion Criteria:
- HIV positive serology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Final cure rate at six months after the end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shyam Sundar, MD, Professor of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Registration Dates
First Submitted
April 3, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (Estimate)
April 4, 2006
Study Record Updates
Last Update Posted (Estimate)
September 12, 2008
Last Update Submitted That Met QC Criteria
September 11, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Euglenozoa Infections
- Leishmaniasis
- Leishmaniasis, Visceral
- Anti-Infective Agents
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- Cholagogues and Choleretics
- Deoxycholic Acid
- Amphotericin B
- Liposomal amphotericin B
- Amphotericin B, deoxycholate drug combination
Other Study ID Numbers
- SS01MZP03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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