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

Phase 2

Terminated

• Conditions: Malaria
• Interventions: Drug: SAR97276A

• Registration Number: NCT00739206
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-15
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 113

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3	SAR97276A	Pediatric patients with severe malaria
Cohort 1	SAR97276A	Adult patients with uncomplicated malaria
Cohort 2	SAR97276A	Pediatric patients with uncomplicated malaria

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Parasite reduction	3 initial days (72h)
Safety assessment	28 days post 1st study drug administration

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇿 Dodoma, Tanzania