Clinical trials: Falciparum Malaria
Uncomplicated Malaria, Asymptomatic Condition
A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers
Malaria is caused by protozoan parasites of the genus Plasmodium and it is the most important parasitic disease in terms of mortality and morbidity.
- Conditions
- Uncomplicated Malaria, Asymptomatic Condition, Falciparum Malaria
- Trial name
- ZYFER-1 (NCT05911828)
- Testing
- ZY19489 + Ferroquine (FQ)
- Where
- Gabon
- Volunteers
- 36 people
- Sponsor
- Zydus Lifesciences Limited
Infections, Vector Borne Diseases
Phase 1b MMV367 PK/PD and Safety in Healthy Adult Volunteers Experimentally Infected With Blood Stage P. Falciparum
This is an open-label, adaptive study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile and safety of MMV367 (the IMP).
- Conditions
- Infections, Vector Borne Diseases, Systemic Inflammatory Response Syndrome, Inflammation
- Trial name
- NCT05979207
- Testing
- MMV367 3mg, P. falciparum IBSM infection, MMV367 5mg
- Where
- 2 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria
Proof-of-Concept Study of MSP3-LSP Vaccine to Protect Against Malaria in Africa
Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days…
- Trial name
- MSP3-POC (NCT01341704)
- Testing
- MSP3-LSP/AlOH, Verorab Vaccine, 0.9% NaCl/Normal Saline
- Where
- Mali
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Vac4All
Malaria
Safety and Protective Efficacy of Genetically Attenuated PfSPZ-GA1 Vaccine in Healthy Dutch Volunteers
This is a first-in-human, randomized clinical trial of PfSPZ-GA1 Vaccine (genetically attenuated PfSPZ) in healthy malaria-naïve adult volunteers. This Phase 1 trial is divided into two stages, Stage A and B.
- Trial name
- NCT03163121
- Testing
- PfSPZ-GA1 Vaccine, PfSPZ Vaccine, Normal Saline
- Where
- 2 sites in Netherlands
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Safety and Immunogenicity of Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545])
This study will be the first time that the candidate malaria vaccine Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]) will be tested in malaria endemic populations.
- Trial name
- NCT00431808
- Testing
- Malaria vaccine AMA1 (PfAMA-1-FVO[25-545], AMA1
- Where
- Mali
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- African Malaria Network Trust
Falciparum Malaria
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
- Trial name
- NCT00894660
- Testing
- Amodiaquine (Test), Amodiaquine (Comparator)
- Where
- Singapore
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Pfizer
Malaria,Falciparum
To Assess the Safety, Immunogenicity and Efficacy of VLPM01 in Healthy, Malaria-Naïve Volunteers
This study is a proof-of-concept, first in human, Phase I, single center study designed to evaluate the safety, tolerability, immunogenicity and experimental efficacy of VLPM01 in healthy, malaria-naïve adult volunteers.
- Trial name
- NCT03867331
- Testing
- 5 microgram VLPM01, 15 microgram VLPM01, 30 microgram VLPM01
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- VLP Therapeutics
Plasmodium Falciparum Malaria
Mass Vaccine and Drug Administration, Bangladesh
This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass…
- Trial name
- MVDA (NCT06068530)
- Testing
- DHA/piperaquine and a SLD-PQ, Study vaccine R21/Matrix-M™
- Where
- 2 sites in Bangladesh
- Volunteers
- 10,000 people
- Sponsor
- University of Oxford
Placental Malaria Infection, HIV Infections
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival.
- Conditions
- Placental Malaria Infection, HIV Infections, Stillbirth, Prematurity
- Trial name
- NCT00270530
- Testing
- Sulfadoxine-pyrimethamine (Fansidar)
- Where
- Zambia
- Volunteers
- 454 people
- Sponsor
- Center for International Health and Development
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
Safety and Immunogenicity in Age De-Escalation of PfSPZ Vaccine in Tanzanian Adults, Children, and Infants
The present trial will evaluate safety and tolerability as well as the vaccine-induced humoral and cellular immune responses in healthy Tanzanian adults, adolescents, children, and infants who receive doses of 1.8x10^6, 9.0x10^5…
- Trial name
- NCT02613520
- Testing
- PfSPZ Vaccine, Normal Saline, PfSPZ Challenge (for CHMI)
- Where
- Tanzania
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria in Pregnancy, Sexually Transmitted Infections
Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea
The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (<2.5 kg) among…
- Conditions
- Malaria in Pregnancy, Sexually Transmitted Infections, Anaemia
- Trial name
- IPTp in PNG (NCT01136850)
- Testing
- chloroquine, sulphadoxine pyrimethamine, LLIN, azithromycin, sulphadoxine pyrimethamine, LLIN
- Where
- Papua New Guinea
- Volunteers
- 2,793 people, healthy volunteers welcome
- Sponsor
- University of Melbourne
Malaria
Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
The objective of this study was to determine the bioequivalence among three commercial tablet formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in combination with artesunate.
- Trial name
- NCT00544024
- Where
- Peru
- Volunteers
- 39 people
- Sponsor
- Centers for Disease Control and Prevention
Plasmodium Falciparum, Plasmodium Vivax
The Malaria Heart Disease Study
The Malaria Heart Disease Study is a prospective longitudinal cohort study of a random sample of approximately 1200 individuals from the state of Acre in Brazil.
- Conditions
- Plasmodium Falciparum, Plasmodium Vivax, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT04445103
- Testing
- Assessment of cardiac function
- Where
- Brazil
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- University Hospital, Gentofte, Copenhagen
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, Burkina Faso
Evaluation of Three Artemisinin-based Combinations for the Treatment of Uncomplicated Malaria in Childreen in Burkina Faso (CHIMIO2)
Bakground In Burkina Faso, since the adoption of this new malaria treatment policy in 2005, several studies evaluating the efficacy and tolerance of ACTs have been carried out by different research teams at different sites…
- Trial name
- CHIMIO2 (NCT04778813)
- Testing
- Artemether-lumefantrine
- Where
- Burkina Faso
- Volunteers
- 1,050 people
- Sponsor
- Centre national de recherche et de formation sur le paludisme
Malaria
Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate
The aim of this study is to evaluate the role of clindamycin and artesunate as possible combination partners for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute…
- Trial name
- JP015 (NCT01002183)
- Testing
- Fosmidomycin
- Where
- Thailand
- Volunteers
- 40 people
- Sponsor
- Jomaa Pharma GmbH
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
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate…
- Trial name
- NCT00541385
- Testing
- pyronaridine artesunate, arthemeter lumefantrine
- Where
- 8 sites in Burkina Faso, Côte d’Ivoire and 6 more
- Volunteers
- 535 people
- Sponsor
- Medicines for Malaria Venture