A Pilot Study for Capacity Building for a Multi-centre, Randomized Trial for Treatment of Kala Azar in Bangladesh
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators:
Community Based Medical College, Bangladesh Dhaka Medical College Directorate General of Health Services of Bangladesh