MS201618_0034 - Phase 2a Proof-of-Concept, Multicenter, Randomized, Open Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of the Combination M5717-pyronaridine as Chemoprevention in Asymptomatic Adults and Adolescents with Plasmodium falciparum Malaria Infection (CAPTURE-2).

Phase 2a Proof-of-Concept, Multicenter, Randomized, Open Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of the Combination M5717-pyronaridine as Chemoprevention in Asymptomatic Adults and Adolescents with Plasmodium falciparum Malaria Infection (CAPTURE-2).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202312609154425

Enrollment

192

Registered

2023-12-14

Start date

2023-09-10

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

M5717 and Pyronaridine tetraphosphate

Atovaquone proguanil hydrochloride

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Participants with Asymptomatic Plasmodium falciparum Malaria with no Fever or other sign of Acute Uncomplicated Malaria and, with Microscopic confirmation using Giemsa-stained thick film, and a Parasitemia of >= 40 to = 45 kilogram (kg) • Participants capable of giving Signed Informed consent which includes Compliance with the requirements and restriction listed in the Informed consent form • Other Protocol defined Inclusion Criteria could apply

Exclusion criteria

Exclusion criteria: • Participants with any disease requiring Chronic Treatment • Participants with any Preplanned surgery during the study • Participants with any previous Treatment with pyronaridine as part of a combination therapy during the last 3 months • Participants with any adequate Hematological, Hepatic, and renal function as defined in the Protocol • Other protocol defined Exclusion Criteria could apply

Design outcomes

Primary

Measure	Time frame
Time to Parasitemia Since Negative Blood Smear after Treatment	—

Secondary

Measure	Time frame
Percentage of Participants with Parasitemia (positive blood smear).;Percentage of Participants with Polymerase Chain Reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to new Infections as determined by Genotyping using PCR Techniques);Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques);Parasite Clearance Time;Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs;Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine	—

Measure

Time frame

Percentage of Participants with Parasitemia (positive blood smear).;Percentage of Participants with Polymerase Chain Reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to new Infections as determined by Genotyping using PCR Techniques);Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques);Parasite Clearance Time;Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs;Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine

—

Countries

Burkina Faso, Gambia, Kenya, Zambia

Contacts

Public ContactHenk Badenhorst

Senior Clinical Research Manager at ICON performing services on behalf of Merck Healthcare KGaA

henk.badenhorst@external.merckgroup.com+27112311900

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026