Status: Recruiting

Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)

This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.

Participants needed: 120

Trial details

Phase: Phase 2Age: 2-12Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Sep 10, 2026Locations: 13

Eligibility criteria

Male and female participants 2 to <12 years of age at screening. [+2]

Participants with signs and symptoms of severe/complicated malaria at screening... [+8]

Status: Recruiting

A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines

The goal of this open-label randomised, controlled, non-inferiority trial is to assess and compare the efficacy, tolerability and safety of a fixed dose TACT artemether-lumefantrine-amodiaquine (ALAQ) to the ACTs artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) (with single low-dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria in patient. The main question it aims to answer is whether ALAQ, a fixed dose TACT, is as efficacious, safe and tolerable in comparison with AL and ASAQ. Participants will be enrolled, admitted and randomised to receive the study drug (ALAQ, AL or ASAQ). Patients will receive directly observed treatments and will be followed up at least once daily for the first 3 days after enrolment followed by weekly visits from D7 up to D42. Patients will be asked to report to the clinics between scheduled visits in case of any illness or other symptoms or complaints.

Participants needed: 1,680

Trial details

Phase: Phase 3Age: 6+Biological sex: AllType: InterventionalSponsor: University of OxfordUpdated: Nov 18, 2025Locations: 1

Eligibility criteria

Male or female, aged ≥6 months (no upper limit unless one is required by local r... [+6]

Signs of severe malaria (adapted from WHO criteria) [+11]

Status: Recruiting

Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria

Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria

Participants needed: 327

Trial details

Phase: Phase 2Age: 2-100Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Jul 30, 2025Locations: 12

Eligibility criteria

Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part... [+3]

Patients with signs and symptoms of severe/complicated malaria at screening or m... [+9]