Clinical trials: Post Kala Azar Dermal Leishmaniasis
Post Kala Azar Dermal Leishmaniasis
Ivermectin Repurposed for the Treatment of PKDL
Background (brief): 1. Burden: Post-Kala-Azar Dermal Leishmaniasis (PKDL) commonly follows visceral leishmaniasis (VL) caused by Leishmania donovani.
- Trial name
- NCT07286604
- Testing
- Ivermectin 6 MG Oral Tablet (2 tablets)
- Where
- Bangladesh
- Volunteers
- 10 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Post Kala Azar Dermal Leishmaniasis
Miltefosine for Children With PKDL
Hypothesis: Primary hypothesis: 1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on body weight and height) for 12 weeks is safe with a cure rate of ≥95%. Secondary hypothesis: 2.
- Trial name
- NCT02193022
- Testing
- Miltefosine
- Where
- Bangladesh
- Volunteers
- 80 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Visceral Leishmaniasis, Post-kala-azar Dermal Leishmaniasis
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
- Trial name
- NCT00486382
- Testing
- Leish-111f + MPL-SE Adjuvant
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Post Kala Azar Dermal Leishmaniasis
Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL
A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard…
- Trial name
- NCT00982774
- Testing
- LEISH-F2 + MPL-SE vaccine
- Where
- Sudan
- Volunteers
- 42 people
- Sponsor
- Access to Advanced Health Institute (AAHI)
PKDL
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
Miltefosine efficacy will be >85%
- Trial name
- NCT01635777
- Testing
- Miltefosine
- Where
- India
- Volunteers
- 37 people
- Sponsor
- AB Foundation
Post-kala-azar Dermal Leishmaniasis
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…
- Trial name
- NCT01975051
- Testing
- Mitefosine
- Where
- Bangladesh
- Volunteers
- 36 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Post-kala-azar Dermal Leishmaniasis
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in…
- Trial name
- NCT03311607
- Testing
- AmBisome
- Volunteers
- 280 people
- Sponsor
- Medecins Sans Frontieres, Netherlands
Post-kala-azar Dermal Leishmaniasis
Repurposing Ivermectin for PKDL Treatment
Burden: Post-Kala-Azar Dermal Leishmaniasis (PKDL) commonly follows visceral leishmaniasis (VL) caused by Leishmania donovani. It is characterized by skin lesions in which parasites can be identified, in a patient who is…
- Trial name
- NCT06251739
- Testing
- Ivermectin 6 Mg Oral Tablet, Miltefosine Oral Capsule
- Where
- Bangladesh
- Volunteers
- 30 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
PKDL - Post-Kala-Azar Dermal Leishmanioid
Short Course Regimens for Treatment of PKDL (Sudan)
This is an open label, randomized non comparative phase II clinical trial conducted on parallel groups, to assess the safety and efficacy of the combination of Paromomycin (20 mg/kg/d) IM for 14 days and Miltefosine (allometric…
- Trial name
- NCT03399955
- Testing
- Paromomycin, Ambisome, Miltefosine
- Where
- Sudan
- Volunteers
- 110 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Cutaneous
A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL
This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL.
- Trial name
- NCT03969134
- Testing
- ChAd63-KH
- Where
- Sudan
- Volunteers
- 86 people
- Sponsor
- University of York
Post-kala-azar Dermal Leishmaniasis
A Study to Assess Safety and Efficacy of a Leishmania Vaccine to Prevent Post Kala Azar Dermal Leishmaniasis (PKDL)
The actual format of the anticipated LEISH3 trial is under review.
- Trial name
- LEISH3 (NCT04107961)
- Testing
- Vaccine
- Sponsor
- University of York
Leishmaniasis, Leishmaniasis, Visceral
Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
This study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis.
- Conditions
- Leishmaniasis, Leishmaniasis, Visceral, Post-kala-azar Dermal Leishmaniasis
- Trial name
- PKDL (NCT05449717)
- Where
- South Sudan
- Volunteers
- 52 people
- Sponsor
- Epicentre
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin-related Neglected Tropical Diseases (Skin NTDs) affect about 1.8 billion people worldwide, particularly in poor and rural communities where healthcare access is limited.
- Conditions
- Skin and Connective Tissue Diseases, Neglected Tropical Diseases, Leprosy, Buruli Ulcer
- Trial name
- SkincAIr (NCT07506967)
- Testing
- A mobile app with AI functionality for diagnosing skin-related NTDs
- Where
- 5 sites in Democratic Republic of the Congo, Ethiopia and 3 more
- Volunteers
- 2,420 people
- Sponsor
- Kenya Medical Research Institute