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Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis

NCT00604955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2014-10-03

No results posted yet for this study

Summary

This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.

Conditions

  • Visceral Leishmaniasis

Interventions

DRUG

Paromomycin sulfate

Paromomycin will be administered intramuscularly at 11 mg/kg, once a day, for 21 consecutive days

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • P K Sinha, MD · Rajendra Memorial Research Institute of Medical Sciences

  • T K Jha, MD · Kalazar Research Centre

  • C P Thakur, MD · Kala-azar Research Centre

  • Shyam Sundar, MD · Kala-azar Medical Research Centre

  • Devendra Nath, MD · Shrimati Hazari Maternity and Medical Care

  • Supriyo Mukherjee, MD · Research Centre for Diabetes, Hypertension and Obesity

  • Amrendra K Aditya, MD · Dr. A.K. Aditya Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-12-31
Completion
2010-01-31

Countries

  • India

Study Locations

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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 NCT00604955 on ClinicalTrials.gov