Clinical trials: Leishmaniasis
Kinetoplastid, Skin Diseases, Parasitic
Diagnosis and Treatment of Leishmania Infections
Patients admitted on this protocol must have an active Leishmania infection. The major objectives of the protocol are to diagnose and classify the Leishmania infection and to provide species-based therapy to study the natural…
- Conditions
- Kinetoplastid, Skin Diseases, Parasitic, Parasitic Diseases, Leishmaniasis
- Trial name
- NCT00344188
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Visceral Leishmaniasis
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months…
- Trial name
- NCT01328457
- Testing
- Paromomycin sulfate
- Where
- 3 sites in Bangladesh
- Volunteers
- 120 people
- Sponsor
- PATH
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
Cutaneous Leishmaniasis
Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants
While vaccination against cutaneous leishmaniasis, a chronic ulcerating protozoan infection of the skin, has been possible for decades using live parasites, the production and storage of live cultures are difficult.
- Trial name
- NCT00001906
- Testing
- Combination of autoclaved leishmania antigen with recombinant human interleukin-12 (rhIL-12) and aluminum hydroxide gel as adjuvants
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cutaneous Leishmaniasis
Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank
The objective of the project is to study the pathogenesis of Leishmania tropica infection in a focus of infection, to learn about relationship of infection in humans with ecological factors such as infection in hyraxes reservoir…
- Trial name
- NCT00737386
- Where
- Israel
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
Visceral Leishmaniasis
Improved Case Detection and Vector Control for Visceral Leishmaniasis
Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country.
- Trial name
- NCT03269006
- Testing
- Inesfly Paint, IDWL (1m), ITN (KO-Tab 123)
- Where
- Bangladesh
- Volunteers
- 202 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Cutaneous Leishmaniases
Efficacy and Safety of Pentamidine (7mg/kg) for Patients With Cutaneous Leishmaniasis Caused by L. Guyanensis
Introduction: Up to the present, have been few studies with pentamidine in the Americas; and there is no consensus regarding the dose used.
- Trial name
- NCT02919605
- Testing
- Single dose of Pentamidine, Two doses of Pentamidine, Three doses of Pentamidine
- Volunteers
- 159 people
- Sponsor
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Cutaneous Leishmaniases
Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World
This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine…
- Trial name
- NCT04515186
- Testing
- Meglumine Antimoniate, Miltefosine, Thermotherapy machine
- Where
- 6 sites in Bolivia, Brazil and 2 more
- Volunteers
- 184 people
- Sponsor
- Drugs for Neglected Diseases
Cutaneous Leishmaniases
Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan
New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable…
- Trial name
- CLeishPOCAFG (NCT03435419)
- Testing
- LoopampTM Leishmania Detection Kit, CL DetectTM Rapid Test
- Volunteers
- 274 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Visceral Leishmaniasis
Amphotericin B Treatment in Visceral Leishmaniasis
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses.
- Trial name
- NCT00310505
- Testing
- Amphotericin B deoxycholate given as daily administration
- Where
- India
- Volunteers
- 1,500 people
- Sponsor
- Banaras Hindu University
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
Cutaneous Leishmaniasis
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony…
- Trial name
- GMCSFSbv (NCT00973128)
- Testing
- GMCSF plus Antimony reduced dose, Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- Hospital Universitário Professor Edgard Santos
Leishmaniasis, Visceral
Combination Therapy in Indian Visceral Leishmaniasis
Rationale The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme.
- Trial name
- NCT00523965
- Testing
- amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine, Liposomal Amphotericin B and Paromomycin Sulfate
- Where
- India
- Volunteers
- 624 people
- Sponsor
- Banaras Hindu University
Cutaneous Leishmaniasis
Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable.
- Trial name
- HECT (NCT01277796)
- Testing
- Heat pack conduction-heat therapy
- Sponsor
- Universidad Peruana Cayetano Heredia
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)
Leishmaniasis, Cutaneous
Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis
Leishmaniasis is a vector-borne disease caused by obligate, intracellular protozoa of the genus Leishmania and transmitted by phlebotomine sandflies.
- Trial name
- NCT05708625
- Testing
- Intralesional Sodium stibogluconate, Intralesional Cryotherapy, Intralesional Voriconazole
- Where
- Libya
- Volunteers
- 136 people
- Sponsor
- Zagazig University
Cutaneous Leishmaniasis
Oral Miltefosine Plus Topical Imiquimod to Treat Cutaneous Leishmaniasis
Cutaneous leishmaniasis is endemic in the New World from approximately the US-Mexican border through Central America and the Northern part of South America down to the level of Rio de Janeiro.
- Trial name
- NCT01380314
- Testing
- Miltefosine + Imiquimod
- Where
- Bolivia
- Volunteers
- 60 people
- Sponsor
- Foundation Fader
Cutaneous Leishmaniasis
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis…
- Trial name
- NCT04340128
- Testing
- Meglumine antimoniate
- Where
- Iran
- Sponsor
- Tehran University of Medical Sciences
Cutaneous Leishmaniasis
Documentation of Patient Outcomes for SSG/Allopurinol Combination Treatment in Ethiopia
Outcomes of patients receiving SSG and Allopurinol combination have never been documented systematically in Ethiopia. Therefore, it is not known how effective this combination is.
- Trial name
- NCT04699383
- Testing
- Sodium Stibogluconate with allopurinol
- Where
- Ethiopia
- Volunteers
- 105 people
- Sponsor
- Institute of Tropical Medicine, Belgium
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