Phase
Condition
N/ATreatment
Pyronaridine
M5717 660mg
M5717 200 mg
Clinical Study ID
Ages 12-55 All Genders
Study Summary
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
Connect with a study center
Groupe de Recherche Action en Sante (GRAS)
Ouagadougou 2357048,
Burkina FasoSite Not Available
Groupe de Recherche Action en Sante (GRAS)
Ouagadougou 06,
Burkina FasoSite Not Available
MRC Unit The Gambia at LSHTM
Banjul,
GambiaSite Not Available
Research Site
Darmstadt,
GermanySite Not Available
Kisumu County Referral Hospital
Kisumu,
KenyaSite Not Available
Kisumu County Referral Hospital
Kisumu 191245,
KenyaSite Not Available
MRC Unit The Gambia at LSHTM
Banjul 2413876,
The GambiaSite Not Available
Ndola Teaching Hospital
Ndola,
ZambiaSite Not Available
Ndola Teaching Hospital
Ndola 901344,
ZambiaSite Not Available

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