Clinical trials: Visceral Leishmaniasis
Visceral Leishmaniasis
Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
The overall objective of this trial is to identify a safe and effective treatment for visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.
- Trial name
- NCT02011958
- Testing
- Liposomal Amphotericin B, Miltefosine
- Where
- 2 sites in Ethiopia
- Volunteers
- 59 people
- Sponsor
- Drugs for Neglected Diseases
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
Invasive Fungal Infections, Neutropenic Fever
Human Bioequivalence Study of Amphotericin B Liposome for Injection
Single-center, randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design to evaluate the human bioequivalence of two Amphotericin B Liposome for Injection formulations
- Conditions
- Invasive Fungal Infections, Neutropenic Fever, Visceral Leishmaniasis
- Trial name
- NCT06977490
- Testing
- Amphotericin B Liposome for Injection (strength: 50 mg, Sichuan Huiyu Pharmaceutical Co., Ltd.), Amphotericin B Liposome for Injection (trade name: Ambisome®, strength: 50 mg, MAH: Gilead Sciences)
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
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
Primary Visceral Leishmaniasis
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.
- Trial name
- NCT05593666
- Testing
- LXE408, AmBisome®
- Where
- 2 sites in India
- Volunteers
- 101 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
The purpose of this study is: 1. To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar (visceral leishmaniasis) subjects who are either treatment naive or…
- Trial name
- NCT00497601
- Testing
- Amphotericin B fat emulsion in visceral leishmaniasis, Amphotericin B fat emulsion, Amphotericin B in fat emulsion
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Banaras Hindu University
Brucelloses, Epidemic Hemorrhagic Fever
Real World Study of Classic Infectious Disease
This study aimed to collect and analyze clinical specimens of patients with classic infectious diseases in the real world. To investigate the epidemiological distribution of classic infectious diseases (brucellosis, epidemic…
- Conditions
- Brucelloses, Epidemic Hemorrhagic Fever, Kala-Azar
- Trial name
- NCT04020536
- Testing
- Antibiotics
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Huashan Hospital
Leishmania Infantum Disease, Leishmaniasis, Visceral
LEISH-PED: Study on Leishmaniasis in Children
Leishmaniasis is an infection caused by Leishmania parasites. In children, it can affect the skin or internal organs. Diagnosis may be delayed because the signs and symptoms can be similar to those of other conditions.
- Conditions
- Leishmania Infantum Disease, Leishmaniasis, Visceral, Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous
- Trial name
- LEISH-PED (NCT07504757)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Meyer Children's Hospital IRCCS
Visceral Leishmaniasis
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
The overall objective of this trial is to identify a safe and effective combination, (coadministration) short course treatment for the treatment of visceral leishmaniasis which could be easily deployed in a control programme and…
- Trial name
- NCT00696969
- Testing
- Amphotericin B Deoxycholate, Ambisome + Miltefosine, Ambisome and Paromomycin
- Where
- 2 sites in India
- Volunteers
- 634 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard…
- Trial name
- NCT03129646
- Testing
- Miltefosine, Paromomycin, Sodium stibogluconate
- Where
- 7 sites in Ethiopia, Kenya and 2 more
- Volunteers
- 439 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Visceral
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian…
- Trial name
- NCT00876824
- Testing
- Amphotericin B Lipid emulsion, Liposomal Amphotericin B
- Where
- 4 sites in India
- Volunteers
- 500 people
- Sponsor
- Bharat Serums and Vaccines Limited
Visceral Leishmaniasis
A Pilot Study for Capacity Building for a Multi-centre, Randomized Trial for Treatment of Kala Azar in Bangladesh
Kala azar (KA) or visceral leishmaniasis (VL) is endemic in several districts of Bangladesh with the highest incidence in Mymensingh, Pabna and Tangail districts.
- Trial name
- NCT01240473
- Testing
- Randomized trial for treatment of kala azar in Bangladesh
- Where
- Bangladesh
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Visceral Leishmaniasis
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner.
- Trial name
- NCT00371995
- Testing
- Liposomal amphotericin B and Miltefosine
- Where
- 2 sites in India
- Volunteers
- 150 people
- Sponsor
- Banaras Hindu University
Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal
Replacement of Insecticides to Control Visceral Leishmaniasis (VL)
Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To control the disease in these three countries a National kala-azar elimination program is ongoing.
- Trial name
- NCT01644682
- Testing
- IWFPL, IDWL, ITN
- Where
- Bangladesh
- Volunteers
- 3,600 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Kala Azar
Miltefosine for Brazilian Visceral Leishmaniasis
Miltefosine will be administered to Brazilian patients with kala azar
- Trial name
- NCT00378495
- Testing
- Miltefosine: initially 2.5 mg/kg/day for 28 days
- Where
- Brazil
- Volunteers
- 80 people
- Sponsor
- AB Foundation
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)
Leishmaniasis, Visceral
Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic…
- Trial name
- VL-DX-EAFR (NCT03646981)
- Testing
- Leishmania Ab Rapid Test (CTK, Biotech)
- Where
- 2 sites in Ethiopia, Kenya
- Volunteers
- 704 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Visceral Leishmaniasis
Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
Visceral leishmaniasis (VL) or kala azar is a neglected tropical disease(NTD) caused by protozoan parasites of the Leishmania donovani complex that are transmitted by phlebotomine sand flies.
- Trial name
- NCT06118749
- Testing
- Antigen detection Rapid Diagnostic Test prototype
- Where
- Kenya
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Primary Visceral Leishmaniasis
LXE408 for Treatment of Visceral Leishmaniasis in Ethiopia, a Proof of Concept Study
This is a randomized, open-label, phase II, single-centre study, with one LXE408 regimen and one calibrator arm with the standard of care SSG combined with PM, to be conducted in male and female adult (≥18 years and <45 years)…
- Trial name
- NCT05957978
- Testing
- LXE408, sodium stibogluconate, Paromomycin
- Where
- Ethiopia
- Volunteers
- 52 people
- Sponsor
- Drugs for Neglected Diseases
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