NCT00157833

A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.

A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (planned)
• Sponsor: Menzies School of Health Research · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

Summary

This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (\>10kg).

Detailed description

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 two fixed dose artemisinin combination regimens: artekin (DHA-Piperaquine) and coartemether (artemether-lumefantrine) 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. Drug administration will be supervised once per day. 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).

Conditions

• Falciparum Malaria
• Vivax Malaria

Interventions

Type	Name	Description
DRUG	Artekin / Coartemther

Timeline

• Start date: 2004-07-01
• Completion: 2005-08-01
• First posted: 2005-09-12
• Last updated: 2006-06-26

Locations

1 site across 1 country: Indonesia