A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.
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.
Drug: Amodiaquine plus artesunate; Artekin
|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 Compare the Efficacy of Artekin and Amodiaquine Plus Artesunate for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua|
- Overall day 42 cure rate (incorporating early and late treatment failures)
- 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 2005|
|Estimated Study Completion Date:||December 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 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157885
|SP9 & SP12 Public Health & Malaria Control Clinics|
|Timika, Papua, Indonesia|
|Principal Investigator:||Ric N Price, MD||Menzies School of Health Research|
|Principal Investigator:||Emiliana Tjitra||National Institute of Health Research and Development, Jakarta, Indonesia|