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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157833
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 26, 2006
National Institute of Health Research and Development (NIHRD), Indonesia
National Health and Medical Research Council, Australia
Wellcome Trust
Information provided by:
Menzies School of Health Research

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 Not Applicable

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  (Clinical Trial)
Enrollment : 750 participants
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 : July 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Overall Cure Rate at Day 42

Secondary Outcome Measures :
  1. Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
  2. Day 42 P.vivax cure rate
  3. Overall day 28 cure rate for P.falciparum
  4. Proportion of patients aparasitaemic on Days 1 and 2
  5. Haematological recovery
  6. Gametocyte Carriage during follow up

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157833

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 (NIHRD), Indonesia
National Health and Medical Research Council, Australia
Wellcome Trust
Principal Investigator: Ric N Price Menzies School of Health Research
Principal Investigator: Emiliana Tjitra National Institute of Health Research and Development

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00157833     History of Changes
Other Study ID Numbers: TIMIKA_FC
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 26, 2006
Last Verified: June 2006

Keywords provided by Menzies School of Health Research:
Uncomplicated malaria

Additional relevant MeSH terms:
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents