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ISRCTN
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ISRCTN14027467
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ClinicalTrials.gov identifier
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Public title
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Radical cure of vivax malaria
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Scientific title
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Open label comparison of Chloroquine (CQ) alone versus CQ plus 5 days unobserved Primaquine or CQ plus 14 days unobserved primaquine
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Acronym
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CqPq
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Serial number at source
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CP1
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Study hypothesis
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Radical cure of vivax malaria requires 14 days primaquine. However a 5 day regimen has been widely recommended. This trial compares the two radical regimens versus no primaquine.
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Lay summary
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Lay summary under review 4
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Ethics approval
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1. Calcultta School of Tropical Medicine approved in early 2003
2. Faculty of Tropical Medicne, Mahidol University approved on 8th December 2005, ref: TM-IRB056/2005
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Study design
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Open label randomised comparison
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Countries of recruitment
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India
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Disease/condition/study domain
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Vivax malaria
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Participants - inclusion criteria
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1. Age > 3 years
2. Fully informed consent to long follow-up
3. Acute uncomplicated vivax malaria
4. Not pregnant
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Participants - exclusion criteria
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1. <3 years
2. Pregnancy
3. Severe disease
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Anticipated start date
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01/04/2003
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Anticipated end date
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01/09/2004
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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150
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Interventions
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1. Chloroquine (25mg base/kg total) only ; 10mg/kg on day 1, 10mg/kg on day 2 then 5mg/kg on day 3
2. Chloroquine (25mg base/kg total as above) followed by primaquine 0.25mg base/kg/day for 5 days-total dose 1.25mg base/kg (75mg in an adult)
3. Chloroquine (25mg base/kg total) followed by primaquine 0.25mg base/kg/ day for 14 days -total dose 3.5mg base/kg (210mg in an adult)
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Primary outcome measure(s)
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Relapse rate
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Secondary outcome measure(s)
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Adverse effects
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Sources of funding
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Wellcome Trust (UK) (reference No. 066439/2/01/2)
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Trial website
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Publications
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Contact name
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Prof
Nicholas
White
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Address
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MORU
Faculty of Tropical Medicine
Mahidol University
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City/town
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Bangkok
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Zip/Postcode
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10400
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Country
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Thailand
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Tel
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+66 (0)2 203 6301
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Email
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nickw@tropmedres.ac
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Sponsor
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Mahidol University (Thailand)
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Address
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Faculty of Tropical Medicine
420/6 Rajvithi Rd
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City/town
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Bangkok
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Zip/Postcode
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10400
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Country
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Thailand
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Date applied
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12/11/2011
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Last edited
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01/05/2012
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Date ISRCTN assigned
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16/11/2011
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