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

November 3, 2014 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1212
        • Dinesh Mondal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miltefosine
Tablet Miltefosine 100 mg daily in two divided doses for 12 weeks.
Drug: Mitefosine
Tablet Miltefosine 100 mg in two devided doses for 12 weeks
Other Names:
  • Brand name: Impavido

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore the association of treatment regimens for visceral leishmaniasis, host immunological, genetical and nutrition factors with Post-kala-azar Dermal Leishmaniasis (PKDL)
Time Frame: Three years
1. PKDL burden among VL patients treated with SSG and miltefosine in the past; 2. Association of serum level of IL-10, TGF-β and serum level of cholesterols before and after treatment of PKDL; 3. mRNA expression of IL-10, TGF-β in skin lesion before and after treatment; 4. association of gene polymorphism of IL-10, TGF-β and PKDL; 5. diagnostic sensitivity of immunofluorescence technique compared to skin slit examination and PCR; and, 6. titer of urine antigens and antibodies before and after treatment of PKDL.
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

University of Nagasaki.

Investigators

  • Principal Investigator: Dinesh Mondal, MB; MD; PhD, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-12057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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