A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall Cure Rate at Day 42
- Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
- Day 42 P.vivax cure rate
- Overall day 28 cure rate for P.falciparum
- Proportion of patients aparasitaemic on Days 1 and 2
- Haematological recovery
- Gametocyte Carriage during follow up
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||August 2005|
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).
|SP9 and SP12 Malaria-Public Health Clinics|
|Timika, Papua, Indonesia|
|Principal Investigator:||Ric N Price||Menzies School of Health Research|
|Principal Investigator:||Emiliana Tjitra||National Institute of Health Research and Development|