Malaria Clinical Trial
Official title:
Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children
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 investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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