The Chloroquine for Influenza Prevention Trial
Information source: National University Hospital, Singapore
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Chloroquine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National University Hospital, Singapore Official(s) and/or principal investigator(s):
Nicholas I Paton, MD FRCP, Study Chair, Affiliation: National University, Singapore
Lawrence Lee, MD PhD, Principal Investigator, Affiliation: National University, Singapore
Summary
A randomised controlled trial to determine the efficacy of chloroquine for the prevention of
influenza
Clinical Details
Official title: A Randomised, Double-blind, Placebo Controlled Trial of Chloroquine for the Prevention of Influenza
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Laboratory-confirmed influenza-like illness
Secondary outcome: Serologically-confirmed influenza infection (symptomatic or asymptomatic)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18 -65
- 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:
- Acute influenza-like illness at screening
- 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
Locations and Contacts
Investigational Medicines Unit, National University Hospital, Singapore 119074, Singapore
Additional Information
Starting date: November 2009
Last updated: February 28, 2010
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