Malaria
Conditions
Brief summary
Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objectives: * To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs) * To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria * To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria * To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A
Detailed description
The total duration per patients will last approximately 28 ± 2 days broken down as follows: * A screening phase up to 12-hours * A 28 ± 2 days study period
Interventions
DRUGSAR97276A
Pharmaceutical form:solution for injection Route of administration: intramuscular
DRUGarthemeter + lumefantrine (ACTs)
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parasite Reduction Ratio (PRR) | at 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of mean Parasitaemia over time (nb/µL) | every 6 hours from baseline up to 72 hours (day 4) |
| Evolution of mean Gametocytes count over time (nb/µL) | from baseline to end of study (day 28 ± 2) |
| Fever Clearance (time to reach Temperature < 38°C) | every 6 hours from baseline up to 72 hours (day 4) |
| General conditions improvement: mean total symptom score over time | every 6 hours from baseline up to 72 hours (day 4) |
| SAR97276 pharmacokinetic profile in plasma and blood | from baseline up to 12 hours after the last study drug intake on (Day 3 |
Countries
Benin, Burkina Faso, Gabon, Kenya
Outcome results
None listed