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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00157885
First received: September 8, 2005
Last updated: June 23, 2006
Last verified: June 2006
  Purpose

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 Intervention
Malaria, Falciparum
Malaria, Vivax
Drug: Amodiaquine plus artesunate; Artekin

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Menzies School of Health Research:

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

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

Estimated Enrollment: 400
Study Start Date: July 2005
Estimated Study Completion Date: December 2005
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).

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157885

Locations
Indonesia
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
Investigators
Principal Investigator: Ric N Price, MD Menzies School of Health Research
Principal Investigator: Emiliana Tjitra National Institute of Health Research and Development, Jakarta, Indonesia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00157885     History of Changes
Other Study ID Numbers: Timika_AMT, Welcome Trust ME028458MES
Study First Received: September 8, 2005
Last Updated: June 23, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Menzies School of Health Research:
Falciparum
Vivax
Papua
Amodiaquine
Artekin
Artemisinin Combination Therapy
Dihydroartemisinin
Piperaquine
Lumefantrine
Artemether

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Artesunate
Amodiaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on October 16, 2014