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

NCT01240473 | Completed DMC

• 1 other identifier: 2007-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visceral Leishmaniasis

Keywords

kala azar; visceral leishmaniasis; diagnosis; drug resistance; Therapeutics; Capacity Building

Outcome Measures

Primary Outcomes (1)

• To develop capacity to evaluate newer regimens for treatment of kala azar in Bangladesh.

  1 year

Secondary Outcomes (1)

• To evaluate response to treatment with 28 injections of SAG

  1 year

Interventions

Randomized trial for treatment of kala azar in Bangladesh DRUG

dose of SAG 20 mg/kg body weight, with a maximum dose of 850 mg/day, for 28 days

Eligibility Criteria

• Age: 5 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Community Based Medical College, Bangladesh: collaborator
• Dhaka Medical College: collaborator
• Directorate General of Health Services of Bangladesh: collaborator

Study Sites (1)

Community-based Medical College, Bangladesh (CBMC,B)

Mymensingh, Dhaka Division, Bangladesh

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral; Disease

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kazi M Jamil, MD, PhD

  Associate Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2010
• First Posted: November 15, 2010
• Study Start: April 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: July 1, 2009
• Last Updated: March 16, 2018

Record last verified: 2010-11

Locations

BA (1)