Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar (AcoV)

NCT03773536 PHASE4 COMPLETED

The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg/kg) for the treatment of uncomplicated P. falciparum malaria patients in Zanzibar. The specific objectives are: * To determine the clinical and parasitological efficacy of artesunate + amodiaquine and primaquine in the treatment of uncomplicated Plasmodium falciparum infection. * To differentiate recurrent infections during follow-up, i.e. recrudescence from new infections, by polymerase chain reaction (PCR). * To evaluate the incidence of adverse events, particularly with regards to potential hematological adverse events of primaquine. * To determine the polymorphism of molecular markers associated with artesunate + amodiaquine tolerance/resistance. * To formulate recommendations, which will enable the Zanzibar Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated or not. * To determine efficacy rate of the first line treatment compared to the first efficacy trial thirteen years ago.

Details

Lead sponsor	Professor Anders Björkman
Phase	PHASE4
Status	COMPLETED
Enrolment	146
Start date	Tue May 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Sep 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Plasmodium Falciparum Malaria

Interventions

• Artesunate-amodiaquine given with single low dose primaquine

Countries

Tanzania