Clinical trials: Malaria, Falciparum
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, Malaria Vaccines
Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6…
- Trial name
- NCT02699099
- Testing
- Vitamin A, Candidate Plasmodium falciparum malaria vaccine, MR-Vac
- Where
- 2 sites in Ghana
- Volunteers
- 699 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
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
Severe Malaria
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
- Trial name
- NCT04675931
- Testing
- Cipargamin, IV Artesunate, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 254 people
- Sponsor
- Novartis Pharmaceuticals
Plasmodium Falciparum Infection
Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective: To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction…
- Trial name
- NCT03660839
- Testing
- Artefenomel (OZ439), Ferroquine (SSR97193)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 140 people
- Sponsor
- Sanofi
Healthy Subjects
Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects
This was a single-center study using induced blood stage malaria infection to characterize the activity of ACT-451840 against early Plasmodium falciparum blood stage infection
- Trial name
- NCT02223871
- Testing
- ACT-451840:, Plasmodium falciparum-infected human erythrocytes:, Artemether 20 mg and lumefantrine 120mg combination tablet:
- Where
- Australia
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Plasmodium Falciparum Infection
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.
- Trial name
- FALCI (NCT02497612)
- Testing
- Ferroquine SSR97193, Artefenomel
- Where
- 12 sites in Benin, Burkina Faso and 5 more
- Volunteers
- 377 people
- Sponsor
- Sanofi
Malaria, Malaria Vaccines
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00289185
- Testing
- RTS,S/AS02D, Engerix-B®, TETRActHib™
- Where
- Tanzania
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.
- Trial name
- NCT00380393
- Testing
- GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine
- Where
- 2 sites in Kenya, Tanzania
- Volunteers
- 894 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Uncomplicated Falciparum Malaria
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Trial name
- NCT01619878
- Testing
- Artemether-lumefantrine (COA566)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa
The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following…
- Trial name
- NCT02207816
- Testing
- Blood sampling, Malaria Vaccine 257049 (MALARIA-055 PRI), Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
- Where
- 3 sites in Burkina Faso, Kenya and 1 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
Plasmodium Falciparum Malaria
Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium…
- Trial name
- CALINA (NCT04300309)
- Testing
- artemether:lumefantrine (2.5 mg:30 mg)
- Where
- 3 sites in Burkina Faso, Democratic Republic of the Congo
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
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
Study to Assess the Vaccine Efficacy Against Malaria Infection, in Children Immunized With the Primary and Yearly Booster of the RTS,S/AS01E Vaccine, as Part of Their Participation in the Malaria-094 (204889/NCT03276962) Study.
The aim of this study was to evaluate the effectiveness of the RTS,S/AS01E malaria vaccine against both clinical and asymptomatic malaria infections by detecting Plasmodium falciparum (P.
- Trial name
- NCT03281291
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Falciparum Malaria
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
- Trial name
- NCT00282919
- Testing
- Azithromycin plus chloroquine
- Where
- 2 sites in Colombia, India
- Volunteers
- 110 people
- Sponsor
- Pfizer
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE