Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.
NCT ID: NCT00739206
Last Updated: 2010-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
113 participants
INTERVENTIONAL
2008-08-31
2009-06-30
Brief Summary
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The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
Adult patients with uncomplicated malaria
SAR97276A
Dose based on body weight
Cohort 2
Pediatric patients with uncomplicated malaria
SAR97276A
Dose based on body weight
Cohort 3
Pediatric patients with severe malaria
SAR97276A
Dose based on body weight
Interventions
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SAR97276A
Dose based on body weight
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Porto-Novo, , Benin
Sanofi-Aventis Administrative Office
Ouagadougou, , Burkina Faso
Sanofi-Aventis Administrative Office
Libreville, , Gabon
Sanofi-Aventis Administrative Office
Dodoma, , Tanzania
Countries
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References
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Held J, Supan C, Salazar CLO, Tinto H, Bonkian LN, Nahum A, Sie A, Abdulla S, Cantalloube C, Djeriou E, Bouyou-Akotet M, Ogutu B, Mordmuller B, Kreidenweiss A, Siribie M, Sirima SB, Kremsner PG. Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients. Malar J. 2017 May 4;16(1):188. doi: 10.1186/s12936-017-1832-x.
Other Identifiers
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ACT10004
Identifier Type: -
Identifier Source: org_study_id
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