Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
1516 participants
INTERVENTIONAL
2009-11-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Chloroquine
Chloroquine
Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks
Placebo
Placebo
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
Interventions
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Chloroquine
Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks
Placebo
Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have the ability to provide informed consent
* If a woman of child-bearing potential, willing to use contraception for the period of the trial
Exclusion Criteria
* History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease
* Pregnancy or breast feeding
* Current use of medication with known serious hepatotoxic effects
* Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin
* Current severe depression (as indicated by current use of antidepressant medication)
* Known serious retinal disease
* Current or recent (within the past 30 days) participation in any other clinical intervention trial.
* Known G6PD deficiency
* Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening
18 Years
65 Years
ALL
Yes
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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National University of Singapore
Principal Investigators
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Nicholas I Paton, MD FRCP
Role: STUDY_CHAIR
National University of Singapore
Lawrence Lee, MD PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Locations
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Investigational Medicines Unit, National University Hospital
Singapore, , Singapore
Countries
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References
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Paton NI, Lee L, Xu Y, Ooi EE, Cheung YB, Archuleta S, Wong G, Wilder-Smith A. Chloroquine for influenza prevention: a randomised, double-blind, placebo controlled trial. Lancet Infect Dis. 2011 Sep;11(9):677-83. doi: 10.1016/S1473-3099(11)70065-2. Epub 2011 May 5.
Other Identifiers
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E/09/482
Identifier Type: -
Identifier Source: org_study_id
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