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Sponsors and Collaborators: |
Menzies School of Health Research NIHRD Wellcome Trust National Health and Medical Research Council, Australia |
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Information provided by: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT00157885 |
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 |
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Malaria, Falciparum Malaria, Vivax |
Drug: Amodiaquine plus artesunate; Artekin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 400 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2005 |
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).
Ages Eligible for Study: | 12 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Indonesia, Papua | |
SP9 & SP12 Public Health & Malaria Control Clinics | |
Timika, Papua, Indonesia |
Principal Investigator: | Ric N Price, MD | Menzies School of Health Research |
Principal Investigator: | Emiliana Tjitra | National Institute of Health Research and Development, Jakarta, Indonesia |
Study ID Numbers: | Timika_AMT, Welcome Trust ME028458MES |
Study First Received: | September 8, 2005 |
Last Updated: | June 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00157885 |
Health Authority: | Australia: National Health and Medical Research Council |
Falciparum Vivax Papua Amodiaquine Artekin |
Artemisinin Combination Therapy Dihydroartemisinin Piperaquine Lumefantrine Artemether |
Artesunate Benflumetol Protozoan Infections Amodiaquine Malaria, Vivax Artemisinine Malaria |
Malaria, Falciparum Artemether Piperaquine Artemisinins Parasitic Diseases Dihydroquinghaosu |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |