Clinical trials: Paludism
Malaria
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria…
- Trial name
- NCT03334747
- Testing
- KAE609, Coartem
- Where
- 9 sites in Gabon, Ghana and 3 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609
- Trial name
- NCT01836458
- Testing
- KAE609
- Where
- Vietnam
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Weekly Dosing of Malarone ® for Prevention of Malaria
The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.
- Trial name
- MALWEEK (NCT00984256)
- Testing
- Atovaquone Proguanil, Procedure - malaria challenge
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria, Malaria,Falciparum
PfSPZ Vaccine Trial in Malian Children
In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of…
- Trial name
- NCT04940130
- Testing
- Sanaria® PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection
Part A -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an additional single dose (400 mg) of DSM265 may be given if gametocytemia develops.
- Trial name
- DSMOZ-2 (NCT02573857)
- Testing
- DSM265, OZ439
- Where
- Australia
- Volunteers
- 16 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
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Malian Children
The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of…
- Trial name
- L9LS (NCT05304611)
- Testing
- L9LS (VRC-MALMAB0114-00-AB) Subcutaneous injection, L9LS (VRC-MALMAB0114-00-AB) intravenous injection
- Where
- 2 sites in Mali
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO.
- Trial name
- NCT01231503
- Testing
- GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B, Tritanrix HepB Hib
- Where
- Malawi
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Pyronaridine Artesunate-Ritonavir Drug-drug Interaction Study
The primary objective of the study is to determine any drug interaction between the antimalarial Pyramax (pyronaridine artesunate) and the protease inhibitor ritonavir in healthy subjects.
- Trial name
- NCT01156389
- Testing
- Ritonavir and Pyramax, Pyramax
- Where
- Switzerland
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
HIV
Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
The purpose of this study is to determine if there is a benefit to taking trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral load suppression and a good clinical response on anti-retroviral…
- Trial name
- TSCQ (NCT01650558)
- Testing
- Standard of Care prophylaxis, Chloroquine (CQ) prophylaxis
- Where
- 2 sites in Malawi
- Volunteers
- 1,499 people
- Sponsor
- University of Maryland, Baltimore
Cure Rate
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
- Trial name
- NCT01860989
- Testing
- KAE609
- Where
- 4 sites in Thailand, Vietnam
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali
Background: The disease malaria affects many people in Mali and other parts of Africa and the world. It is caused by germs spread by mosquito bites. Malaria may be mild.
- Trial name
- NCT03510481
- Testing
- PfSPZ Vaccine, Normal Saline, artemether 20mg/lumefantrine 120mg (AL)
- Where
- Mali
- Volunteers
- 478 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, Plasmodium Vivax
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine.
- Trial name
- NCT01157897
- Testing
- VMP001, P. vivax sporozoite challenge
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria,Falciparum
Evaluate the Infectivity Equivalence of Current and New Lots of Plasmodium Falciparum Strain NF54
Objectives: Primary: To characterize the infectivity of the new lot of Plasmodium falciparum strain 3D7 within the standard WRAIR CHMI model as compared to the current lot (historical data) Secondary: To assess safety of the new…
- Trial name
- NCT03882528
- Testing
- Plasmodium falciparum malaria parasite
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria, Lymphatic Filariasis
Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study
The purpose of this study is to determine whether repeated ivermectin mass drug administrations to Burkinabé villagers, performed in three week intervals over the rainy-season, is well-tolerated and safe, and also effective in…
- Trial name
- RIMDAMAL (NCT02509481)
- Testing
- Ivermectin, Albendazole
- Where
- 2 sites in United States, Burkina Faso
- Volunteers
- 2,712 people, healthy volunteers welcome
- Sponsor
- Colorado State University
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07235033)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 3 sites in Côte d’Ivoire, Gabon and 1 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
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
Malaria Vaccine
Malaria Vaccine Safety and Immunogenicity Study in Healthy Adults
Targeted malaria elimination (TME), which comprises appropriate case management by village health workers, vector control and mass drug administration, is currently being implemented through pilot projects in selected villages in…
- Trial name
- RTSS (NCT02992119)
- Testing
- RTS,S/AS01B Fractional dose, Double RTS,S/AS01E Fractional dose, RTS,S/AS01E Standard dose
- Where
- Thailand
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Intermittent Preventive Treatment In Pregnancy (IPTp)
Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
- Trial name
- NCT01103063
- Testing
- Azithromycin plus chloroquine, sulfadoxine-pyrimethamine
- Where
- 9 sites in Benin, Kenya and 3 more
- Volunteers
- 2,891 people, healthy volunteers welcome
- Sponsor
- Pfizer