Clinical Trials Logo

Clinical Trial Summary

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. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.


Clinical Trial Description

Total duration was 63 days for each participant. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02497612
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 2
Start date July 25, 2015
Completion date September 23, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05400655 - Anti-malaria MAb in Kenyan Children Phase 2
Completed NCT02773979 - PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States Phase 1
Completed NCT03660839 - Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria Phase 2
Terminated NCT00988507 - Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria Phase 2
Recruiting NCT05750459 - Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria Phase 4
Completed NCT02020330 - Optimising Operational Use of Artemether-lumefantrine Comparing 3 Day Versus 5 Day Phase 3
Active, not recruiting NCT05816330 - L9LS MAb in Malian Adults Phase 2
Completed NCT02353494 - Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria N/A
Completed NCT00744133 - Malaria Challenge With NF54 Strain Phase 1
Active, not recruiting NCT05304611 - Anti-malaria MAb in Malian Children Phase 2
Completed NCT03014258 - A Systems Biology Approach to Malaria Immunity Phase 1
Completed NCT03168854 - Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of Three or Five Administrations of GAP3KO Sporozoites Phase 1
Completed NCT00371189 - Adenovirus Vaccine for Malaria Phase 1
Not yet recruiting NCT05025761 - Reducing Malaria Transmission in Forest-going Mobile and Migrant Populations in Myanmar N/A
Completed NCT00379821 - Chloroquine Alone or in Combination for Malaria in Children in Malawi Phase 3
Completed NCT04329104 - Anti-malaria MAb in Mali Phase 2
Completed NCT03589794 - rCSP/AP10-602 [GLA-LSQ] Vaccine Trial Phase 1
Completed NCT02780154 - PfSPZ Challenge in Non-immune Adults in Baltimore, USA Phase 1
Completed NCT02143934 - Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity Phase 4
Completed NCT02663700 - Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso Phase 1