Clinical trial NCT05974267: Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria Infection
Keywords: Plasmodium falciparum
Chemoprevention
Malaria
Plasmodium eukaryotic translation elongation factor 2 (PeEF2)
Exposure response
Adults
Adolescents
Asymptomatic Infection
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2023-08-03
Enrollment: 192
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open Label
Primary purpose: TREATMENT

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 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 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 \<= 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 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

Primary outcomes:
measure: Time to Parasitemia Since Negative Blood Smear after Treatment
timeFrame: From Study Start Day 1 up to End of Study (approximately 12 weeks)
Secondary outcomes:
measure: Percentage of Participants with Parasitemia (positive blood smear).
timeFrame: From Study Start Day 1 up to End of Study (approximately 12 week)
measure: 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)
timeFrame: From Study Start Day 1 up to End of Study (approximately 12 weeks)
measure: Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques)
timeFrame: From Study Start Day 1 up to End of Study (approximately 12 weeks)
measure: Parasite Clearance Time
timeFrame: Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
timeFrame: From Study Start Day 1 up to End of Study (approximately 12 Weeks)
measure: Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine
timeFrame: Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and (24 hours) on Day 2
Other outcomes:
Locations:
city: Ouagadougou 06
country: Burkina Faso
facility: Groupe de Recherche Action en Sante (GRAS)
city: Banjul
country: Gambia
facility: MRC Unit The Gambia at LSHTM
city: Kisumu
country: Kenya
facility: Kisumu County Referral Hospital
city: Ndola
country: Zambia
facility: Ndola Teaching Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: