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.
Status | Completed |
Enrollment | 36 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Bangladesh | Dinesh Mondal | Dhaka |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | University of Nagasaki. |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Explore the association of treatment regimens for visceral leishmaniasis, host immunological, genetical and nutrition factors with Post-kala-azar Dermal Leishmaniasis (PKDL) | 1. PKDL burden among VL patients treated with SSG and miltefosine in the past; 2. Association of serum level of IL-10, TGF-ß and serum level of cholesterols before and after treatment of PKDL; 3. mRNA expression of IL-10, TGF-ß in skin lesion before and after treatment; 4. association of gene polymorphism of IL-10, TGF-ß 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 | Yes |
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