To determine the safety and efficacy of 4 ACTs (amodiaquine-artesunate, AQ-AS, dihydroartemisinin-piperaquine, DHA-PQ, artemether-lumefantrine, AL, Mefloquine-artesunate, MQAS) when administered to pregnant women with P. falciparum infection during the second and the third trimester and collect explanatory variables for treatment failure (PCR-corrected) and for recurrent parasitaemia. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms.
SpecificTo compare the efficacy of AL, AQ-AS, MQ-AS and DHA-PQ in terms of:Peripheral parasite clearance by 14, 28, 42 and 63 days after start of treatment with or without genotyping.Haematological recovery by 14, 28, 42 and 63 days post-treatment and at delivery.Birth weight measured within 72 hrs of delivery.Preventing placenta P. falciparum malaria.To describe the safety profile of AL, AQ-AS, MQ-AS and DHA-PQ in terms ofTolerability.Incidence of adverse events until one year post partum.To determine the relation between drug pharmacokinetics (Day 7 levels of the partner drug) and response to treatment.To asses the in vitro susceptibility of P. falciparum isolates collected before treatment to several drugs, including the partner drug tested, and to correlate their IC50 to treatment response.
The ITM's CTU is in charge of project management, monitoring, pharmacovigilance, clinical data management and biostatistics.
|Effective start/end date||1/12/07 → 30/09/14|
- Bill & Melinda Gates Foundation: €989,519.00