A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
Condition: Post-kala-azar Dermal Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Mitefosine
Intervention type(s): Drug
Intervention description(s): Tablet Miltefosine 100 mg in two devided doses for 12 weeks
Other intervention name(s): Brand name: Impavido
Intervention MeSH terms: Miltefosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kala- azar; PKDL; Treatment; Pathogenesis; Bangladesh