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

Sponsor

Menzies School of Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT00157833

Collaborator

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia (Other), National Health and Medical Research Council, Australia (Other), Wellcome Trust (Other)

750

Enrollment

Location

Duration (Months)

57.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Falciparum Malaria Vivax Malaria	Drug: Artekin / Coartemther	N/A

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).

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2004

Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Overall Cure Rate at Day 42 []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients at least one 1year of age and weighing more than 10kg.
Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
Fever (axillary temperature >37.5C) or history of fever in the last 48 hours.
Able to participate in the trial and comply with the clinical trial protocol
Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent

Exclusion Criteria:

Pregnancy or lactation
Inability to tolerate oral treatment
Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (See Appendix II)
Known hypersensitivity or allergy to artemisinin derivatives
Serious underlying disease (cardiac, renal or hepatic)
Parasitaemia >4%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SP9 and SP12 Malaria-Public Health Clinics	Timika	Papua	Indonesia

Sponsors and Collaborators

Menzies School of Health Research
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
National Health and Medical Research Council, Australia
Wellcome Trust

Investigators

Principal Investigator: Ric N Price, Menzies School of Health Research
Principal Investigator: Emiliana Tjitra, National Institute of Health Research and Development