Post-kala-azar Dermal Leishmaniasis Clinical Trial
Official title:
A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
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.
Background:Post-kala-azar dermal leishmaniasis is a skin disorder caused by the Leishmania
donovani and usually develops after treatment for visceral leishmaniasis. The public health
importance of this condition is that it plays as an inter-epidemic reservoir of visceral
leishmaniasis.It is believed that the condition is associated with sodium stibogluconate
(SSG) monotherapy for visceral leishmaniasis; however evidence is lacking to support this.
Further no study has been carried out to explore the pathogenesis of PKDL in Bangladesh.
Also no information is available related to development of PKDL after treatment of VL with
miltefosine monotherapy in Bangladesh.Better knowledge on pathogenesis of PKDL will help to
predict and design intervention to prevent the development of PKDL. This will help to reduce
the numbers of inter-epidemic reservoir for VL and hence will contribute to the national
kala-azar elimination program.
Objectives:1. To investigate the incidence of PKDL after SSG or Miltefosine mono-therapy for
VL; 2. To investigate serum level of IL-10, TGF-β and markers of lipid metabolism (serum
cholesterols) before and after treatment of PKDL; 3. To investigate the mRNA expression of
IL-10, TGF-β in skin lesion of PKDL; 4. To investigate the association of gene polymorphism
of IL-10, TGF-β and PKDL; 5. To develop a new diagnostic tool for diagnosis of PKDL by
detection of LD antigen in the skin tissue by punch biopsy using immunofluorescence
technique; and, 6. To investigate leishmania antigens and anti-leishmania antibodies in
urine before and after treatment of PKDL and evaluate possibility to use them as diagnostic
tools.
Methods:1. The incidence of PKDL after treatment for VL will be investigated through
studying a retrospective cohort which will be identified by cross-sectional survey; 2. serum
level of cytokines and lipid profile will be measured respectively by cytometric bed-array
and autoanalyzer before and after treatment for PKDL; 3. mRNA expression of cytokines will
be measured real-time PCR before and after treatment for PKDL; 4. gene polymorphism will be
investigated by DNA sequencing; 5. the new diagnostic tool will be developed using
immunofluorescence technique; and, 6. urine antigens and antibodies will be detected by
ELISA.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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