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

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.