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

Summary

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.

Timeline

Start

2017-05-09

Primary completion

2017-09-25

Completion

2017-09-25

Drugs

Indications