Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children

Conditions
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Malaria

Intervention / Treatment
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* Drug: SAR97276A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Adult patients with uncomplicated malaria | Drug: SAR97276A<br>* Dose based on body weight<br>|
| Experimental: Cohort 2<br>Pediatric patients with uncomplicated malaria | Drug: SAR97276A<br>* Dose based on body weight<br>|
| Experimental: Cohort 3<br>Pediatric patients with severe malaria | Drug: SAR97276A<br>* Dose based on body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parasite reduction |  | 3 initial days (72h) | 
| Safety assessment |  | 28 days post 1st study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uncomplicated, severe, treatment, Plasmodium Falciparum