Malaria
Conditions
Keywords
uncomplicated, severe, treatment, Plasmodium Falciparum
Brief summary
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.
Detailed 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.
Interventions
DRUGSAR97276A
Dose based on body weight
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h | 3 initial days |
Secondary
| Measure | Time frame |
|---|---|
| Parasite reduction | 3 initial days (72h) |
| Safety assessment | 28 days post 1st study drug administration |
Countries
Benin, Burkina Faso, Gabon, Tanzania
Outcome results
None listed