Status:
TERMINATED
Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.
Lead Sponsor:
Sanofi
Conditions:
Malaria
Eligibility:
All Genders
6-65 years
Phase:
PHASE2
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...
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 hospita...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00739206
Start Date
August 1 2008
End Date
June 1 2009
Last Update
June 16 2010
Active Locations (4)
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1
Sanofi-Aventis Administrative Office
Porto-Novo, Benin
2
Sanofi-Aventis Administrative Office
Ouagadougou, Burkina Faso
3
Sanofi-Aventis Administrative Office
Libreville, Gabon
4
Sanofi-Aventis Administrative Office
Dodoma, Tanzania