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Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

NCT00216346 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 667

Last updated 2014-10-03

No results posted yet for this study

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

  • Visceral Leishmaniasis

Interventions

DRUG

Paromomycin sulfate

DRUG

Amphotericin B

Sponsors & Collaborators

Principal Investigators

  • Prof S. Sundar · Kala-azar Research Centre

  • Prof T.K. Jha · Kalazar Research Centre

  • Prof C.P. Thakur · Kalazar Research Centre

  • Dr. S.K. Bhattacharya · Rajendra Memorial Research Institute of Medical Sciences (ICMR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Completion
2004-11-30

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216346 on ClinicalTrials.gov