Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Inclusion criteria:

• Patients diagnosed with symptomatic infection by Plasmodium falciparum microscopically confirmed in blood smear at Day-1 visit
• Fever (tympanic or rectal temperature ≥ 38 C) or documented history of fever within the last 24h
• Asexual parasitemia of ≥ 2 000 parasites/μL in blood smear at D-1 visit
• Signed Informed Consent Form by the parents or legal guardian
• Age: 12 to 17 years old for step 1
• Age: 2 to 11 years old for step 2 and step 3

Exclusion criteria:

• Participation in another clinical trial within the last 3 months or participation within a different cohort in this PDY11737 clinical trial or participation to previous trial with SAR97276
• Documented history of adequate treatment with antimalarials expected to be effective within the preceding 72 hours
• Severe concomitant disease (including concomitant febrile illnesses or infection)
• Any sign suggestive of severe malaria
• Severe malnutrition
• Asexual parasitemia: Plasmodium falciparum > 100,000 parasites/μL in blood smear at D-1 visit
• Previous treatment within 3 weeks prior to inclusion, and concomitant treatment with potent CYP3A4 inhibitors or CYP3A4 inducers or CYP2D6 substrates or potent CYP2D6 inhibitors
• Known serious adverse event reaction or hypersensitivity to Artemisinin-Based Combination Therapy (ACTs) or any contraindications from the positive control therapy (Artemisinin Combined Treatments) or warning/precaution of use as defined in the respective National Product Labeling
• Pregnant or breast-feeding women
• Women of childbearing potential not protected by effective contraceptive method of birth control, or not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g.: double barrier method), and/or who are unwilling or unable to be tested for pregnancy,
• CPK above 3 ULN,
• Underlying hepatobiliary disease or ALT>3 ULN.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.