Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.
The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.
Full description
The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult patients with uncomplicated malaria will be enrolled in cohort 1
- Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
- Pediatric patients with severe malaria will be enrolled in cohort 3
- Plasmodium falciparum malaria confirmed in blood smear
- Fever within the last 24 hours.
Exclusion criteria
- Treatment with an antimalarial agent within 72h of screening
- Severe concomitant disease
- Pregnant or breast-feeding women
- Women of child bearing potential not protected by an effective method of birth control
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial design
Primary purpose
Allocation
Interventional model
Masking
113 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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