Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis

October 2, 2014 updated by: PATH

A Phase 3 Multicenter, Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Injectable Paromomycin in Patients With Visceral Leishmaniasis

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment

667

Phase

  • Phase 3

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

    • Bihar
      • Agam Kuan, Patna, Bihar, India, 800 007
        • Rajendra Memorial Research Institute of Medical Sciences (ICMR)
      • Brahmpura, Muzaffarpur, Bihar, India, 842003
        • Kalazar Research Centre
      • Patna, Bihar, India, 800001
        • Kalazar Research Centre
      • Rambagh Road Muzaffarpur, Bihar, India, 842001
        • Kala-azar Medical Research Centre

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

3 years to 53 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 5-55 years (inclusive) of either gender.
  • Newly diagnosed VL or VL treatment failure confirmed by spleen or bone marrow aspirate.
  • Clinical signs and symptoms compatible with VL: fever of over two weeks duration and splenomegaly.
  • Biochemical and haematological test values as follows:

    • Haemoglobin > 5.0g/100mL
    • White blood cell count > 1 x109/L
    • Platelet count > 50 x 109/L
    • AST, ALT and alkaline phosphatase < 3 times upper normal limit
    • Prothrombin time < 5 seconds above control
    • Serum creatinine levels within normal limits
    • Serum potassium levels within normal limits
  • HIV negative

Exclusion Criteria:

  • A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
  • Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
  • An abnormal baseline audiogram (presentation with 75 dB or higher at 8KHz or below) and/or a history of significant vestibular or auditory dysfunction.
  • Proteinuria (> 2+).
  • A history of allergy or hypersensitivity to aminoglycosides.
  • A history of major surgery within the last two weeks.
  • Pregnancy or lactation. [Note: women of childbearing age must use an adequate form of contraception (documented) or agree to a period of sexual abstinence during the treatment phase of the study.]
  • Previous treatment for VL within two weeks of enrolment into the study.
  • Prior treatment failures with paromomycin or amphotericin B.

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
(1) To compare the safety of injectable paromomycin to amphotericin B when administered in the proposed dosage regimens.
(2) To compare the efficacy of injectable paromomycin to amphotericin B with regards to final cure rates.

Secondary Outcome Measures

Outcome Measure
- Characterization of the pharmacokinetics of injectable paromomycin in adults and children with VL
- Comparison of initial cure rates for the two regimens
- Comparison of clinical improvement rates for the two regimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Prof S. Sundar, Kala-azar Research Centre
  • Principal Investigator: Prof T.K. Jha, Kalazar Research Centre
  • Principal Investigator: Prof C.P. Thakur, Kalazar Research Centre
  • Principal Investigator: Dr. S.K. Bhattacharya, Rajendra Memorial Research Institute of Medical Sciences (ICMR)

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

June 1, 2003

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

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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