Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
|ClinicalTrials.gov Identifier: NCT01361269|
Recruitment Status : Unknown
Verified May 2011 by Zentopharm GmbH.
Recruitment status was: Not yet recruiting
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Fosmidomycin and clindamycin||Phase 2|
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The goal of this study is to assess a new drug combination, fosmidomycin-clindamycin. The primary objective of the study is to assess and compare the efficacy, safety and tolerance (between sites) of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children in Mozambique and Gabon.
The secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of Plasmodium falciparum to fosmidomycin.
The trial will include 100 children aged 3-10 years, divided between clinical sites of Gabon and Mozambique.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||December 2011|
Experimental: Fosmidomycin and clindamycin treatment
All the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Drug: Fosmidomycin and clindamycin
The study drugs will be co-administered under supervision by a study physician or nurse 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).
- Cure rate [ Time Frame: Day 28 ]Cure rate at day 28 will be determined by PCR
- cure rate [ Time Frame: day 7 ]The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361269
|Contact: Saadou Issifou, MD PhDemail@example.com|
|Contact: Ana Babic, PhDfirstname.lastname@example.org|
|Medical Research Unit, Albert Schweitzer Hospital||Not yet recruiting|
|Contact: Saadou Issifou 0024106106256 email@example.com|
|Principal Investigator:||Saadou Issifou, MD PhD||Medical Research Unit, Albert Schweitzer Hospital|