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

NCT01975051 | Completed Phase 4 DMC

• 1 other identifier: PR-12057
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-kala-azar Dermal Leishmaniasis

Keywords

Kala- azar; PKDL; Treatment; Pathogenesis; Bangladesh

Outcome Measures

Primary Outcomes (1)

• 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-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

Study Arms (1)

Miltefosine

EXPERIMENTAL

Tablet Miltefosine 100 mg daily in two divided doses for 12 weeks.

Drug: Mitefosine

Interventions

Mitefosine DRUG

Tablet Miltefosine 100 mg in two devided doses for 12 weeks

Also known as: Brand name: Impavido

Miltefosine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of Visceral Leishmaniasis
• Presence of hypopigmented rash
• Rk39 strip test positive
• Written informed consent from the participant

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of Nagasaki.: collaborator

Study Sites (1)

Dinesh Mondal

Dhaka, Dhaka Division, 1212, Bangladesh

Location

MeSH Terms

Conditions

Leishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dinesh Mondal, MB; MD; PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 4, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 5, 2014

Record last verified: 2012-11

Locations

BA (1)