Malaria, Falciparum Clinical Trial
Official title:
A Randomized Trial to Compare the Efficacy of Artekin and Amodiaquine Plus Artesunate for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
The primary aim of the comparative trial is to assess the relative safety and efficacy of two artemisinin containing regimens: amodiaquine plus artesunate (AAQ) and artekin both administered once daily for 3 days.
With the emergence of species of multi drug resistant P.falciparum across the archipelago
the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate
in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of P.
falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern
provinces.
This trial sets out to assess the efficacy of artekin and amodiaquine plus artesunate and
artekin against both P.falciparum and P. vivax.
and their safety profiles.
Patients who present to an established rural outpatient clinic in Timika, Papua with
symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will
after laboratory confirmation of the diagnosis and having given informed consent to
participate in the trial, be enrolled in the study. Patients will be treated as out-patients
and then seen daily for the first week until aparasitaemic and thereafter at weekly visits
to the clinic.
The data used from this trial will be used to make a public health decision to determine a
suitable alternative first line antimalarial in the Timika region. In order to ensure that
the data gathered will be relevant to the clinical setting in which the drugs will be used,
drug administration of medication will be deliberately designed to mimic conditions that
will be experienced with widespread deployment (eg once daily supervision).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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