Efficacy and Safety of the paediatric formulation (dispersible tablet) of Coartem® in Children (weighing 5 kg to less than 35 kg ) with uncomplicated Plasmodium falciparum malaria

Update Il y a 5 ans
Reference: EUCTR2012-001333-14

Woman and Man

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Extract

To confirm the efficacy of the Coartem pediatric formulation in infants and children with a body weight of ≥5 kg and <35 kg suffering from P. falciparum malaria by testing the hypothesis that Coartem 6-dose regimen pediatric formulation is non-inferior to the presently used Coartem 6-dose regimen of crushed conventional tablet formulation on the 28-day Polymerase Chain Reaction (PCR)-corrected parasitological cure rate.


Inclusion criteria

  • This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused by Plasmodium falciparum in children

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