Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar
Status:
Completed
Trial end date:
2017-09-25
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Professor Anders Björkman
Collaborators:
Ministry of Health and Social Welfare, Zanzibar Uppsala University Zanzibar Malaria Elimination Programme