Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children
This is an open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.
The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children|
- Day 28 cure rate >95% [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Day 7 cure rate of 100% [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
- Parasite Clearance Time [ Time Frame: 0-7 days ] [ Designated as safety issue: No ]
- Fever Clearance Time [ Time Frame: 0-7 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Single arm study. Co-administration of Fosmidomycin and Clindamycin.
Drug: Fosmidomycin and Clindamycin co-administration
Fosmidomycin sodium syrup at a concentration of 250mg/5ml and clindamycin hydrochloride syrup at a concentration of 75mg/5ml. Administered in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg)
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|Centro de Investigacao em Saude da Manhica|
|Principal Investigator:||Quique Bassat, PhD||CRESIB, Barcelona|