- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739206
Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.
A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Porto Novo, Benin
- Sanofi-Aventis Administrative Office
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Ouagadougou, Burkina Faso
- Sanofi-Aventis Administrative Office
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Libreville, Gabon
- Sanofi-Aventis Administrative Office
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Dodoma, Tanzania
- Sanofi-Aventis Administrative Office
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cohort 1
Adult patients with uncomplicated malaria
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Dose based on body weight
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Experimental: Cohort 2
Pediatric patients with uncomplicated malaria
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Dose based on body weight
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Experimental: Cohort 3
Pediatric patients with severe malaria
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Dose based on body weight
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
Time Frame: 3 initial days
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3 initial days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Parasite reduction
Time Frame: 3 initial days (72h)
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3 initial days (72h)
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Safety assessment
Time Frame: 28 days post 1st study drug administration
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28 days post 1st study drug administration
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACT10004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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