Uncomplicated Malaria Clinical Trial
Official title:
A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)
Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an
acute infection. Recurrent infections can be associated with a febrile illness, a cumulative
risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after
both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we
have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen.
In Papua a retrospective study found very low effectiveness for unsupervised treatment. If
true this has profound effects on treatment policy, suggesting that greater efforts are
needed to encourage adherence to treatment.
We propose a cluster randomized, controlled, open label trial to assess the effectiveness of
unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria.
Since the risk of recurrent P. vivax is high in patients with either P. vivax or P.
falciparum, both infections will be included in the study. The study will be conducted in
Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at
village health posts and provided with schizontocidal treatment plus primaquine radical cure
which will be either supervised or unsupervised depending on which cluster the clinic is in.
Participants will be followed up for 6 months and assessed in regular intervals for the
presence of patent and sub-patent malaria. The outcome of the study will contribute to an
improved treatment scheme for uncomplicated malaria in this area.
n/a
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