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A Randomised Trial of Artekin and Artesunate & Amodiaquine for Uncomplicated Malaria in Timika, Papua, Indonesia.

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ClinicalTrials.gov Identifier: NCT00157885
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : June 26, 2006
National Institute of Health Research and Development (NIHRD), Indonesia
Wellcome Trust
National Health and Medical Research Council, Australia
Information provided by:
Menzies School of Health Research

Brief Summary:
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.

Condition or disease Intervention/treatment
Malaria, Falciparum Malaria, Vivax Drug: Amodiaquine plus artesunate; Artekin

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 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Primary Outcome Measures :
  1. Overall day 42 cure rate (incorporating early and late treatment failures)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
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 5kg.
  • Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
  • Fever (axillary temperature >37.5oC) 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
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00157885

SP9 & SP12 Public Health & Malaria Control Clinics
Timika, Papua, Indonesia
Sponsors and Collaborators
Menzies School of Health Research
National Institute of Health Research and Development (NIHRD), Indonesia
Wellcome Trust
National Health and Medical Research Council, Australia
Principal Investigator: Ric N Price, MD Menzies School of Health Research
Principal Investigator: Emiliana Tjitra National Institute of Health Research and Development, Jakarta, Indonesia

ClinicalTrials.gov Identifier: NCT00157885     History of Changes
Other Study ID Numbers: Timika_AMT
Welcome Trust ME028458MES
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:
Artemisinin Combination Therapy

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