Trials / Completed
CompletedNCT00216346
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 667 (planned)
- Sponsor
- PATH · Academic / Other
- Sex
- All
- Age
- 5 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paromomycin sulfate | |
| DRUG | Amphotericin B |
Timeline
- Start date
- 2003-06-01
- Completion
- 2004-11-01
- First posted
- 2005-09-22
- Last updated
- 2014-10-03
Locations
4 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00216346. Inclusion in this directory is not an endorsement.