Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children
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|ClinicalTrials.gov Identifier: NCT01464138|
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : November 3, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Fosmidomycin and Clindamycin co-administration||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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)
- Day 28 cure rate >95% [ Time Frame: 28 days ]
- Day 7 cure rate of 100% [ Time Frame: Day 6 ]
- Parasite Clearance Time [ Time Frame: 0-7 days ]
- Fever Clearance Time [ Time Frame: 0-7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464138
|Centro de Investigacao em Saude da Manhica|
|Principal Investigator:||Quique Bassat, PhD||CRESIB, Barcelona|