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

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 Overview

• Status: Completed
• Conditions: Vivax Malaria; Falciparum Malaria
• Intervention / Treatment: Drug: Artekin / Coartemther

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 Type: Interventional
• Enrollment: 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Papua
    • Timika, Papua, Indonesia
      • SP9 and SP12 Malaria-Public Health Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall Cure Rate at Day 42

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Menzies School of Health Research
• Collaborators: National Health and Medical Research Council, Australia; Wellcome Trust; National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
• Investigators: Principal Investigator: Ric N Price, Menzies School of Health Research; Principal Investigator: Emiliana Tjitra, National Institute of Health Research and Development

Publications and helpful links

General Publications

• Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion: August 1, 2005

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): June 26, 2006
• Last Update Submitted That Met QC Criteria: June 23, 2006
• Last Verified: June 1, 2006

More Information

Terms related to this study

• Keywords: Uncomplicated malaria; Coartemether; Artekin; Papua
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Malaria, Falciparum; Malaria, Vivax
• Other Study ID Numbers: TIMIKA_FC