Clinical trials: Paludism
Plasmodium Falciparum Infection, Malaria
L9LS MAb in Malian Adults
The purpose of this study is to evaluate the safety and tolerability of a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf)…
- Trial name
- NCT05816330
- Testing
- L9LS (VRC-MALMAB0114-00-AB)
- Where
- 3 sites in Mali
- Volunteers
- 490 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria,Falciparum
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya.
- Trial name
- EPiTOMISE (NCT03178643)
- Testing
- Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ), Dihydroartemisinin-Piperaquine (DP)
- Where
- Kenya
- Volunteers
- 246 people
- Sponsor
- Duke University
Malaria, Febrile Illness
Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: TESTsmART Aim 2 - Nigeria
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
- NCT04428385
- Testing
- Testing incentive, Conditional artemisinin combination therapy subsidy
- Where
- Nigeria
- Volunteers
- 2,205 people
- Sponsor
- Duke University
Drug-Drug Interaction, HIV Infection
Dihydroartemisinin-Piperaquine in the Context of Antiretroviral Therapy
Open-label prospective intensive pharmacokinetic study of dihydroartemisinin-piperaquine (DP) in HIV-infected children on efavirenz (EFV)-, lopinavir/ritonavir (LPV/r)-, or dolutegravir (DTG)-based antiretroviral therapy (ART)…
- Trial name
- DPART (NCT04487145)
- Testing
- Dihydroartemisinin-piperaquine
- Where
- 2 sites in Uganda
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Malaria
A Study to Evaluate the Pharmacokinetics of Oral Formulations of MMV390048 Administered Fasted to Healthy Volunteers
This study will be conducted in a single centre, as an open single dose two parallel cohorts design with oral doses of MMV390048 administered in healthy male and female subjects between 18 to 55 years of age.
- Trial name
- NCT02554799
- Testing
- MMV390048 formulation A, MMV390048 formulation B
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria Infection
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
This study evaluates the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and…
- Trial name
- NCT05974267
- Testing
- M5717 60 mg, Pyronaridine, Atovaquone-Proguanil
- Where
- 4 sites in Burkina Faso, Kenya and 2 more
- Volunteers
- 192 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Malaria, Seizures
Aggressive Antipyretics for Fever Reduction in CNS Malaria
The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.
- Conditions
- Malaria, Seizures, Coma, Parasitemia
- Trial name
- NCT03399318
- Testing
- Acetaminophen, Ibuprofen
- Where
- 3 sites in Malawi, Zambia
- Volunteers
- 256 people
- Sponsor
- University of Rochester
Falciparum Malaria
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS)…
- Trial name
- NCT00403260
- Testing
- Pyronaridine - artesunate, Mefloquine plus artesunate
- Where
- 9 sites in Burkina Faso, Cambodia and 5 more
- Volunteers
- 1,271 people
- Sponsor
- Medicines for Malaria Venture
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
Plasmodium Falciparum, Malaria
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria
Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.
- Trial name
- NCT02450578
- Testing
- DSM265 400mg, Plasmodium falciparum sporozoite challenge, Malarone
- Where
- Germany
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria
Safety and Immunogenicity of Pfs25M-EPA/AS01 and Pfs230D1M-EPA/AS01 Vaccines, Transmission Blocking Vaccines Against Plasmodium Falciparum, at Full and Fractional Dosing in Adults in Mali
Background: Researchers are looking for new ways to control and eradicate malaria. They want to test vaccines to block malaria transmission in adults in Mali. These vaccines work by inducing antibodies in a person.
- Trial name
- NCT02942277
- Testing
- Pfs25M-EPA, Pfs230D1M-EPA, AS01
- Where
- Mali
- Volunteers
- 301 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
Background: Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies.
- Trial name
- NCT03989102
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 324 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment
A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system.
- Trial name
- PACT (NCT01722734)
- Testing
- Text message reminders
- Where
- Ghana
- Volunteers
- 1,140 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Malaria, Malaria Vaccines
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated…
- Trial name
- NCT01345240
- Testing
- GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, Infanrix/Hib™ vaccine
- Where
- 2 sites in Burkina Faso, Ghana
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation
This study aims to investigate the concentration dependent effects of OZ439 on the clearance of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum inhibitory concentration (MIC) of OZ439.
- Trial name
- NCT01713621
- Testing
- OZ439
- Where
- 3 sites in Thailand
- Volunteers
- 25 people
- Sponsor
- Medicines for Malaria Venture
Malaria
Piperaquine Granule Formulation Relative Bioavailability and Food Effect Study in Healthy Volunteers.
This trial aims to characterise the pharmacokinetic (PK) profile and estimate drug exposure of a single oral dose of piperaquine (PQP) in a dispersible granule formulation compared to the PQP hard tablet formulation in the fasted…
- Trial name
- PedPQP(BA/FE) (NCT05930782)
- Testing
- Piperaquine Tetraphosphate uncoated tablets, Piperaquine Tetraphosphate dispersible granules
- Where
- Tanzania
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria,Falciparum
Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F
This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or subcutaneously at escalating dose levels in healthy, malaria naïve, adults.
- Trial name
- TB31F (NCT04238689)
- Testing
- TB31F
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Malaria,Falciparum, Child, Only
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study
A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether…
- Trial name
- RTSS-SMC (NCT04319380)
- Testing
- Tetanus/diphtheria toxoids, SMC with SP+AQ, RTS,S/AS01
- Where
- 2 sites in Burkina Faso, Mali
- Volunteers
- 5,098 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Malaria Diagnosis
Validation of RealAmp Method for the Diagnosis of Malaria in Endemic Areas of Brazil
Worldwide, approximately 2 billion people live in areas at risk for malaria with morbidity surpassing 250 million cases, with approximately 800,000 deaths, per year.
- Trial name
- NCT02371395
- Testing
- Realtime amplification (RealAmp)
- Where
- Brazil
- Volunteers
- 1,000 people
- Sponsor
- Centers for Disease Control and Prevention