Status:
COMPLETED
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Malaria Infection
Eligibility:
All Genders
12-55 years
Phase:
PHASE2
Brief 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 infecti...
Eligibility Criteria
Inclusion
- 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 \<= 10,000 Asexual Parasites/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 Compliance with the requirements and restriction listed in the Informed consent form
- Other Protocol defined Inclusion Criteria could apply
Exclusion
- 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
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2024
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05974267
Start Date
November 28 2023
End Date
December 29 2024
Last Update
October 8 2025
Active Locations (4)
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1
Groupe de Recherche Action en Sante (GRAS)
Ouagadougou, Burkina Faso
2
Kisumu County Referral Hospital
Kisumu, Kenya
3
MRC Unit The Gambia at LSHTM
Banjul, The Gambia
4
Ndola Teaching Hospital
Ndola, Zambia