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ISRCTN
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ISRCTN32978789
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ClinicalTrials.gov identifier
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Public title
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Clinical and laboratory assessment of antimalarial drug efficacy in Lao PDR: an open, randomised comparison of artesunate plus mefloquine versus dihydroartemisinin-piperaquine (Artekin) for the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic
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Scientific title
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Acronym
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N/A
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Serial number at source
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065146
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Study hypothesis
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An open, randomised comparison of artesunate plus mefloquine versus dihydroartemisinin-piperaquine (Artekin) for the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Laos
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Disease/condition/study domain
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Uncomplicated falciparum malaria
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Participants - inclusion criteria
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1. Patients or their guardians gave fully informed written consent
2. Had a density of asexual P. falciparum of 1000 to 200,000 per microlitre of blood
3. Were aged more than one year
4. Had an axillary temperature of more than 37.5°C or history of fever in the previous three days
5. Were likely to stay in the hospital until parasite clearance and complete the 42-day follow up period
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Participants - exclusion criteria
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1. Pregnant or lactating women
2. Patients who took a full course of any antimalarials in the previous three days
3. Patients with signs of severe malaria
4. Those with history of allergy or contraindication to the study drugs
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Anticipated start date
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20/05/2004
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Anticipated end date
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20/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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220
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Interventions
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1. Oral Artesunate-Mefloquine (AM)
2. Dihydroartemisinin-piperaquine (Artekin)
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Primary outcome measure(s)
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Parasitological and clinical responses to treatment.
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Secondary outcome measure(s)
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1. Parasite and fever clearance times
2. Gametocytaemia
3. Changes in haematocrit following antimalarial treatment
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Sources of funding
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1. The Western Pacific Regional Office of the World Health Organisation (Philippines)
2. The Wellcome Trust (UK) (grant ref: 065146)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16903879
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Contact name
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Dr
Mayfong
Mayxay
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Address
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Mahosot Hospital
Microbiology Laboratory
Mahosot Road
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City/town
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Vientiane
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Zip/Postcode
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PO Box 5
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Country
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Laos
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Tel
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+856 (0)21 250752
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Fax
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+856 (0)21 242168
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Email
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mmayxay@yahoo.com
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270143
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Fax
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+44 (0)1865 280467
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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22/07/2005
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Last edited
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08/09/2008
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Date ISRCTN assigned
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22/07/2005
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