Plasmodium Falciparum Infection Clinical Trial
Official title:
Efficacy and Safety of Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum and Plasmodium Vivax Malaria in Timika, Indonesia
This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in Timika, Indonesia with a 42 day follow up period.
Dihydroartemisinin-piperaquine (DHA-Pip) is part of the current national guidelines for the
treatment of uncomplicated malaria in Indonesia. In order to guarantee safe and efficacious
treatment for all patients diagnosed with uncomplicated malaria in the area, it is essential
to monitor the effectiveness of the recommended treatment from a clinical perspective and
assess whether the provided treatment is safe for recipients. This trial re-evaluates the
local efficacy and safety of DHA-Pip for P. falciparum and P. vivax infections.
Patients with uncomplicated malaria attending a public health care facility in Timika,
Papua, Indonesia, who meet the study inclusion criteria will be enrolled, treated on site
with DHA-Pip and followed up for 42 days. The follow-up will consist of a fixed schedule of
check-up visits and corresponding clinical and laboratory examinations. On the basis of the
results of these assessments, the patients will be classified as having therapeutic failure
(early or late) or an adequate response. The proportion of patients experiencing therapeutic
failure and drug related adverse events during the follow-up period will be used to estimate
the efficacy and safety of the study drug. PCR analysis will be used to distinguish between
a true recrudescence due to treatment failure and episodes of reinfection.
The outcome of the proposed project will have a direct impact on the decision making process
of the Indonesian Ministry of Health on whether there is a need to alter the existing
antimalarial treatment guidelines.
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