Clinical Research Directory

Key Inclusion criteria (Core phase) 1. Male or female patients ≥ 10 kg of body weight. 2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/µL at the time of pre-screening with or without other Plasmodium spp. co-infection. 3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally) 4. Negative pregnancy test for patients of childbearing potential 5. Signed informed consent was obtained before any assessment is performed; for minors, signed informed consent was obtained from parent/legal guardian. If the parent/legal guardian was unable to read and write, then a witnessed consent according to local ethical standards was permitted. Patients who were capable of providing assent, must have provided it along with parent/legal guardian consent or as per local ethical standards 6. The patient and/or their parent/legal guardian was able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and was likely to complete the study as planned. Key Exclusion criteria (Core phase) 1. Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization) 2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19) 3. Severe malnutrition. For patients ≥ 12 years: body mass index (BMI) \< 16.0. For children \< 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC \< 115 mm) 4. Repeated vomiting (defined as \> 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as \> 3 watery stools in the 24 hours prior to start of screening) 5. Clinically relevant abnormalities of electrolyte balance which required correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia 6. Anemia (hemoglobin level \<7 g/dL) 7. Any surgical or medical condition which might have significantly altered the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment), or which may have jeopardized the patient in case of participation in the study. 8. Any of the following: * Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) \> 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin * Total bilirubin \> 3 x ULN * Resting QT interval corrected by Fridericia's formula (QTcF) \> 450 ms at screening 9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life was unknown) 10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease 11. Pregnant or nursing (lactating) patients.