NCT00310505

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
Last Updated

September 12, 2008

Status Verified

September 1, 2008

First QC Date

April 3, 2006

Last Update Submit

September 11, 2008

Conditions

Visceral Leishmaniasis

Keywords

visceral leishmaniasisamphotericin BKala-azar

Outcome Measures

Primary Outcomes (1)

  • Final cure rate at six months after the end of treatment

Interventions

Amphotericin B deoxycholate given as daily administrationDRUG

Eligibility Criteria

Age2 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parasitologically proved kala-azar

You may not qualify if:

  • HIV positive serology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kala-azar Medical Research Center

Muzaffarpur, Bihar, 221005, India

Location

Related Publications (1)

  • 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.

    PMID: 17682988DERIVED

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Shyam Sundar, MD

    Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

January 1, 2003

Last Updated

September 12, 2008

Record last verified: 2008-09

Locations

IN(1)