Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

Last updated: October 7, 2025
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

Pyronaridine

M5717 660mg

M5717 200 mg

Clinical Study ID

NCT05974267
MS201618_0034
  • Ages 12-55
  • All Genders

Study Summary

This study will evaluate 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 adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with Asymptomatic Plasmodium falciparum Malaria with no Fever or othersign of Acute Uncomplicated Malaria and, with Microscopic confirmation usingGiemsa-stained thick film, and a Parasitemia of >= 40 to <= 10,000 AsexualParasites/Microliter (μL) of Blood.

  • Axillary Temperature < 37.0 degree Celcius (ºC) or oral/Tympanic/rectal Temperature< 37.5ºC; without history of fever during the previous 48 hours.

  • Have a body weight >= 45 kilogram (kg)

  • Participants capable of giving Signed Informed consent which includes Compliancewith the requirements and restriction listed in the Informed consent form

  • Other Protocol defined Inclusion Criteria could apply

Exclusion

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 combinationtherapy during the last 3 months

  • Participants with any adequate Hematological, Hepatic, and renal function as definedin the Protocol

  • Other protocol defined Exclusion Criteria could apply

Study Design

Total Participants: 192
Treatment Group(s): 5
Primary Treatment: Pyronaridine
Phase: 2
Study Start date:
November 28, 2023
Estimated Completion Date:
December 29, 2024

Connect with a study center

  • Groupe de Recherche Action en Sante (GRAS)

    Ouagadougou 2357048,
    Burkina Faso

    Site Not Available

  • Groupe de Recherche Action en Sante (GRAS)

    Ouagadougou 06,
    Burkina Faso

    Site Not Available

  • MRC Unit The Gambia at LSHTM

    Banjul,
    Gambia

    Site Not Available

  • Research Site

    Darmstadt,
    Germany

    Site Not Available

  • Kisumu County Referral Hospital

    Kisumu,
    Kenya

    Site Not Available

  • Kisumu County Referral Hospital

    Kisumu 191245,
    Kenya

    Site Not Available

  • MRC Unit The Gambia at LSHTM

    Banjul 2413876,
    The Gambia

    Site Not Available

  • Ndola Teaching Hospital

    Ndola,
    Zambia

    Site Not Available

  • Ndola Teaching Hospital

    Ndola 901344,
    Zambia

    Site Not Available

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