Clinical trials: Protozoan Infections
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Malaria, HIV Infections
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell…
- Trial name
- PROMOTE-PIs (NCT00993031)
- Testing
- Lopinavir/ritonavir, Efavirenz, Zidovudine
- Where
- Uganda
- Volunteers
- 389 people
- Sponsor
- University of California, San Francisco
Skin Diseases, Parasitic
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
- Trial name
- CL Detect™ (NCT01769612)
- Testing
- No Intervention
- Where
- 2 sites in Tunisia
- Volunteers
- 168 people
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Trial of a Falciparum Malaria Protein (FMP012), E. Coli-expressed PfCelTOS, in Healthy Malaria-Naive Adults
Malaria has remained a major concern for the US military. During World War II, malaria was the leading cause of disease and non-battle injury with 500-700 men infected per day, resulting in 24,000 malaria-related casualties.(10)…
- Trial name
- NCT01540474
- Testing
- Group 1: 10 ug FMP012 with 2 ug GLA-SE, Group 2: 10 ug FMP012 with 5 ug GLA-SE, 50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Dose Escalation PfSPZ-CVac
Background: People get malaria from bites from infected mosquitos. Researchers are studying a vaccine strategy. They will give people malaria parasites by injecting them with live infectious malaria parasites with antimalarial…
- Trial name
- NCT03083847
- Testing
- Chloroquine Phosphate, Pyrimethamine, Sanaria PfSPZ Challenge
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, HIV Infections
HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and children bear the greatest brunt of both diseases. No single existing intervention is likely to control malaria in Africa.
- Trial name
- PROMOTE-PEDS (NCT00978068)
- Testing
- Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Efavirenz (EFV)
- Where
- Uganda
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Plasmodium Falciparum
NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1
The purpose of this study is to determine whether a new investigational malaria vaccine is safe, well tolerated and effective against experimental exposure to malaria when given to healthy people with no previous exposure to…
- Trial name
- NCT00392015
- Testing
- NMRC-M3V-Ad-PfCA, NMRC-MV-Ad-PfC, NMRC-M3V-Ad-PfCA
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Healthy
Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model
The main purpose of this study was to assess the chemoprophylactic activity and dose-exposure-response relationship of single oral dose of M5717 administered after direct intravenous inoculation (DVI) of Plasmodium falciparum…
- Trial name
- NCT04250363
- Testing
- PfSPZ Challenge, Palcebo, M5717 30 mg
- Where
- Netherlands
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Intestinal Amebiasis
Ameparomo Capsules 250 mg Drug Use Investigation
This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
- Trial name
- NCT02680665
- Volunteers
- 120 people
- Sponsor
- Pfizer
Malaria, Vivax
Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine
This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.
- Trial name
- NCT05270265
- Testing
- Pvs25-IMX313/Matrix-M1
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria,Falciparum, Malaria
Pyronaridine in Healthy Adult Participants Infected With Blood Stage Malaria
This is an open-label, adaptive study that will utilise the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile of pyronaridine.
- Conditions
- Malaria,Falciparum, Malaria, Malaria Recrudescence, Parasitemia
- Trial name
- NCT05287893
- Testing
- Pyronaridine, P. falciparum IBSM infection
- Where
- 2 sites in Australia
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria
Experimental Falciparum Transmission to Anopheles
This is a single-centre, open-label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria parasite (gametocytes) to mosquito vectors.
- Trial name
- EFITA (NCT02431637)
- Testing
- Administration of the malaria inoculum, Piperaquine Phosphate 480 mg
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Vaginitis, Bacterial Vaginosis
Point of Care Diagnosis of Vaginal Infections
Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and…
- Conditions
- Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
- Trial name
- PAT (NCT06438575)
- Testing
- Xpert® Xpress MVP test, Usual Care
- Where
- United States
- Volunteers
- 351 people
- Sponsor
- Sharon L Hillier
Malaria,Falciparum
Safety and Immunogenicity of the Malaria Vaccine, R21/MatrixM, in Healthy Thai Adults
Malaria remains one of the leading causes of morbidity and mortality worldwide. Plasmodium falciparum is a complex pathogen with numerous immune evasion mechanisms which has added layers of complexity to the development of safe…
- Trial name
- R21/Matrix-M (NCT05252845)
- Testing
- R21/Matrix-M vaccination, DHA-PIP, PQ
- Where
- Thailand
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Malaria, Falciparum
Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas.
- Trial name
- NCT00223990
- Testing
- FMP1/AS02A, RabAvert
- Where
- Kenya
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Trypanosomiasis, African, Sleeping Sickness
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
The ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of Human African trypanosomiasis due to Trypanosoma brucei rhodesiense (r-HAT): melarsoprol in patients with stage 2…
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection
- Trial name
- NCT03974178
- Testing
- Fexinidazole
- Where
- 2 sites in Malawi, Uganda
- Volunteers
- 45 people
- Sponsor
- Drugs for Neglected Diseases
Malaria
Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute…
- Trial name
- NCT00440999
- Testing
- Pyronaridine artesunate, Chloroquine
- Where
- 5 sites in Cambodia, India and 2 more
- Volunteers
- 456 people
- Sponsor
- Medicines for Malaria Venture
Malaria, Febrile Illness
Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: TESTsmART Aim 2 - Kenya
Highly subsidized first-line antimalarials (artemisinin combination therapy or ACT) are available over the counter in the private retail sector in most malaria-endemic countries.
- Trial name
- NCT04428307
- Testing
- Conditional artemisinin combination therapy subsidy, Testing incentive
- Where
- Kenya
- Volunteers
- 5,696 people
- Sponsor
- Duke University
Malaria,Falciparum, Children, Only
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)
A double-blind, individual randomised trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine…
- Trial name
- RTSS-SMC (NCT03143218)
- Testing
- RABIPUR®, RTS,S/AS01, SMC with SP+AQ
- Where
- 2 sites in Burkina Faso, Mali
- Volunteers
- 5,920 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Malaria
Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under…
- Trial name
- NCT02783820
- Testing
- MMV390048 40 mg, MMV390048 80 mg, MMV390048 120 mg
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture