CompletedPhase 4

A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)

Bangladesh36 participantsStarted 2013-01

Plain-language summary

We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL; anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its pathogenesis \& PKDL patients are genetically predisposed; diagnostic tool based on immunofluorescence technique will be more sensitive than slit skin examination for diagnosis of PKDL.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * History of Visceral Leishmaniasis * Presence of hypopigmented rash * Rk39 strip test positive * Written informed consent from the participant Exclusion Criteria: * Any medical condition that may affect the safety of the patient during study procedure * Any condition which comprises the ability to comply the study procedure * Presence of splenomegaly * Posotive skin smear for mycobacterium leprae * Positive skin smear for fungus * Pregnancy test positive

What they're measuring

Explore the association of treatment regimens for visceral leishmaniasis, host immunological, genetical and nutrition factors with Post-kala-azar Dermal Leishmaniasis (PKDL)

Timeframe: Three years

Trial details

NCT IDNCT01975051

SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

View on ClinicalTrials.gov More Post-kala-azar Dermal Leishmaniasis trials