A Pilot Study for Capacity Building for a Multi-centre, Randomized Trial for Treatment of Kala Azar in Bangladesh

This study has been completed.
Sponsor:
Collaborators:
Community Based Medical College, Bangladesh
Dhaka Medical College
Directorate General of Health Services of Bangladesh
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01240473
First received: November 7, 2010
Last updated: November 12, 2010
Last verified: November 2010
  Purpose

Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh with the highest incidence in Mymensingh, Pabna and Tangail districts. ICDDR,B is involved in a project for improving the surveillance of KA in Trishal, Mymensingh since 2005. Improvement of case detection is necessary for both surveillance purposes and better control. The aims of this pilot study are to assess some newer techniques for diagnosis of KA using blood and urine samples of suspected cases; and evaluate response to treatment with sodium stibogluconate to which resistance has been reported in India, considered to be a part of the same zone harboring the disease agent Leishmania donovani and transmitted by the same vector Phlebotomas argentipes (sand-fly). No data is currently available on response to sodium stibogluconate in KA patients in Bangladesh. Although a number of new drugs have been evaluated in the treatment of KA in India and Kenya, no trial has so far been conducted in Bangladesh. A team of researchers from GlaxoSmithKline (UK) had recently visited Bangladesh to evaluate if it would be possible to conduct a Phase-III clinical trial with sitamaquine. They interacted with scientists of ICDDR,B and expressed their interest to help develop ICDDR,B's capacity in order to include Bangladesh as one of the sites for the planned, multi-centre, Phase-III trial of sitamaquine; India and Nepal are two other possible sites for the trial. The aims of the proposed study are to train physicians and laboratory personnel in preparation for the future drug trial(s) on KA as well as to compare different tests for its diagnosis that might improve case detection at the field level and used for research purposes. The investigators will also examine in greater detail the different Leishmania species circulating in the area of Mymensingh and whether treatment failure and occurrence of Post Kala azar Dermal Leishmaniasis (PKDL) is associated with certain species.


Condition Intervention
Visceral Leishmaniasis
Drug: Randomized trial for treatment of kala azar in Bangladesh

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study for Capacity Building for a Multi-centre, Randomized Trial for Treatment of Kala Azar in Bangladesh

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • To develop capacity to evaluate newer regimens for treatment of kala azar in Bangladesh. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate response to treatment with 28 injections of SAG [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: April 2007
Study Completion Date: July 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Randomized trial for treatment of kala azar in Bangladesh
    dose of SAG 20 mg/kg body weight, with a maximum dose of 850 mg/day, for 28 days
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • KA will be enrolled into the study:

    • fever for >2 weeks
    • at least one of the the following criteria- splenomegaly, darkening of the skin, and weight loss
    • a positive rK39 dipstick test.

Exclusion Criteria:

  • children under five years of age\
  • pregnant women
  • patients who are suffering simultaneously from any other serious illness which is unrelated to kala azar (for example, tuberculosis, cancer, etc).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240473

Locations
Bangladesh
Community-based Medical College, Bangladesh (CBMC,B)
Mymensingh, Dhaka, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Community Based Medical College, Bangladesh
Dhaka Medical College
Directorate General of Health Services of Bangladesh
Investigators
Principal Investigator: Kazi M Jamil, MD, PhD Associate Scientist
  More Information

No publications provided

Responsible Party: Dr. Kazi M Jamil, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01240473     History of Changes
Other Study ID Numbers: 2007-008, 2007-008
Study First Received: November 7, 2010
Last Updated: November 12, 2010
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
kala azar
visceral leishmaniasis
diagnosis
drug resistance
Therapeutics
Capacity Building

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014