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ISRCTN
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ISRCTN50708498
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ClinicalTrials.gov identifier
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Public title
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A randomised community based study to assess the safety, efficacy of dihydroartemisinin-piperaquine (artekin) for the treatment of uncomplicated falciparum malaria
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Scientific title
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Acronym
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AU Study
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Serial number at source
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061330
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Study hypothesis
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Artekin is an exciting, new and relatively low cost antimalarial drug. It is a fixed coformulation containing dihydroartemisinin and piperaquine. The two drugs have been used extensively before as single agents. The objectives of the trial are:
1. To determine the optimum regimen of artemisinin derivative for maximum efficacy of the dihydroartemisinin-piperaquine combination
2. To compare the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3)
3. To assess the drug in terms of safety and tolerability in adults and children
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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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Open label randomised controlled trial
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Countries of recruitment
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Viet Nam
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Disease/condition/study domain
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Malaria
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Participants - inclusion criteria
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1. Adults or children
2. Symptomatic of malaria infection, i.e. history of fever or presence of fever more than 37.5 °C
3. Microscopic confirmation of asexual stages of P. falciparum or mixed infection (5/500 white blood cells)
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Participants - exclusion criteria
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1. Pregnancy or lactation
2. P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000 /µl)
3. Signs or symptoms of severe malaria
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Anticipated start date
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01/08/2002
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Anticipated end date
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01/11/2004
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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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To be added - recruitment completed on 1st August 2004
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Interventions
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Open label randomised controlled trial comparing the efficacy of dihydroartemisinin-piperaquine to that of the antimalarial treatment in current use i.e. mefloquine-artesunate three-day regimen (MAS3).
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Primary outcome measure(s)
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The 56 day (community) cure rates are the markers of therapeutic efficacy for this trial.
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Secondary outcome measure(s)
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Secondary endpoints are frequency of adverse events in the two Artekin groups.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 061330)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=14723988
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Contact name
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Dr
Jeremy
Farrar
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Address
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Hospital for Tropical Diseases
Oxford University Clinical Research Unit
190 Ben Ham Tu
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City/town
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Ho Chi Minh City
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Zip/Postcode
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5
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Country
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Viet Nam
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Tel
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+84 8 8362225
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Fax
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+84 8 9238904
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Email
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jeremyjf@hcm.vnn.vn
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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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14/10/2005
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Last edited
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13/12/2007
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Date ISRCTN assigned
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14/10/2005
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