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Trial registered on ANZCTR


Registration number
ACTRN12611000497909
Ethics application status
Approved
Date submitted
11/05/2011
Date registered
12/05/2011
Date last updated
1/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised placebo-controlled trial to investigate the use of paracetamol in the treatment of influenza
Scientific title
A randomised double-blind placebo-controlled trial to investigate whether paracetamol lengthens the duration of viral shedding in the treatment of patients with influenza
Secondary ID [1] 260080 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza infection 265779 0
Condition category
Condition code
Public Health 265899 265899 0 0
Other public health
Infection 265933 265933 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paracetamol, oral, coated tablet (1g four times daily for 5 days)
Intervention code [1] 264519 0
Treatment: Drugs
Comparator / control treatment
Placebo, oral, coated tablets identical in appearance to the intervention drug but containing no paracetamol (four times daily for 5 days)
Control group
Placebo

Outcomes
Primary outcome [1] 266686 0
Area under the curve for quantitative PCR viral analysis
Timepoint [1] 266686 0
Days 0 to 5
Secondary outcome [1] 276193 0
The proportion of patients with a greater than 2 log10 decrease in viral load at day 2
Timepoint [1] 276193 0
At day 2 compared with day 0
Secondary outcome [2] 276194 0
The proportion of patients with an undetectable viral load by RT-PCR
Timepoint [2] 276194 0
On days 2 and 5
Secondary outcome [3] 276195 0
Viral culture TCID50
Timepoint [3] 276195 0
On days 1 and 5
Secondary outcome [4] 276196 0
Influenza symptom score profile. Participants will use a standardised symptom score to record the severity of 7 influenza symptoms (cough, nasal obstruction, sore throat, fatigue, headache, myalgia and feverishness) according to a 4 point scale (from 0, absent to 3, severe) on a daily basis.
Timepoint [4] 276196 0
Days 0 to 5
Secondary outcome [5] 276197 0
Time to resolution of illness, defined as the time from enrollment to the start of the first 24 hour period in which all 7 symptoms were scored as absent (0) or mild (1).
Timepoint [5] 276197 0
Within days 0 to 14
Secondary outcome [6] 276198 0
AUC analysis of health status by visual analogue scale (VAS)
Timepoint [6] 276198 0
Over days 0 to 5
Secondary outcome [7] 276199 0
An analysis of the primary outcome according to temperature profile, cytokine profile and viral load at baseline.
Timepoint [7] 276199 0
Days 0 to 5

Eligibility
Key inclusion criteria
Onset of an influenza like illness in the past 48 hours: history of fever or documented temperature greater than or equal to 37.8 degree celsius, and at least one of cough, sore throat, rhinorrhea, headache, myalgia, fatigue, or malaise
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Influenza illness severe enough to warrant hospital admission.
A history of allergy or sensitivity or other contraindication to paracetamol or opiates.
Subjects using paracetamol or NSAIDS (not including low dose aspirin) regularly who are unwilling or unable to discontinue use during the trial period.
Recent treatment with oseltamivir.
HIV infection.
Current pregnancy.
Current treatment with oral corticosteroids or other immunosuppressant drugs.
Any other safety concern at the investigator’s discretion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be explained by the study investigator(s) verbally and with written information in the form of a participant information sheet provided in advance. Informed consent in written form will be obtained and the participant will be screened for eligibility. All participants will undergo routine medical assessment. A randomisation sequence, determining the order of allocation of intervention drug or placebo drug chronologically with each enrolled participant, will be generated by a statistician. A third party, Wellington Hospital Pharmacy Department, not directly involved with the study, will dispense the study drug according to this schedule. Study medication will be marked 'paracetamol/placebo' and coded numerically such that the identity the medication may only determined by the third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
18/07/2011
Date of last participant enrolment
Anticipated
Actual
24/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 3437 0
New Zealand
State/province [1] 3437 0
Wellington

Funding & Sponsors
Funding source category [1] 265007 0
Government body
Name [1] 265007 0
Health Research Council of New Zealand
Country [1] 265007 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level 7, Clinical Services Block
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 264102 0
Hospital
Name [1] 264102 0
Capital & Coast District Health Board
Address [1] 264102 0
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country [1] 264102 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266981 0
Central Regional Ethics Committee
Ethics committee address [1] 266981 0
Ministry of Health
Level 2, 1-3 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 266981 0
New Zealand
Date submitted for ethics approval [1] 266981 0
Approval date [1] 266981 0
12/01/2011
Ethics approval number [1] 266981 0
CEN/10/12/057

Summary
Brief summary
Paracetamol is recommended for the routine treatment of fever and systemic symptoms in influenza. However, this recommendation is contrary to evidence which suggests that the presence of fever is protective in infections. This study aims to investigate whether the regular use of an antipyretic (paracetamol) during acute infection with influenza may prolong viral shedding and clinical symptoms.
Trial website
Trial related presentations / publications
The study manuscript is in preparation for submission to a peer-reviewed medical journal. A draft study abstract was presented to the Thoracic Society of Australia and NZ at their Adelaide conference in April 2014. A further presentation will be made at the American Thoracic Society conference in San Diego in May 2014.
Public notes

Contacts
Principal investigator
Name 32548 0
Dr Kyle Perrin
Address 32548 0
MRINZ Private Bag 7902 Wellington 6242
Country 32548 0
New Zealand
Phone 32548 0
+64 (04)805 0147
Fax 32548 0
+64 (04) 389 5707
Email 32548 0
[email protected]
Contact person for public queries
Name 15795 0
Dr Dr Irene Braithwaite or Dr Kyle Perrin
Address 15795 0
MRINZ
Private Bag 7902
Wellington 6242
Country 15795 0
New Zealand
Phone 15795 0
+64 (04)805 0147
Fax 15795 0
Email 15795 0
[email protected] or [email protected]
Contact person for scientific queries
Name 6723 0
Dr Dr Irene Braithwaite
Address 6723 0
MRINZ
Private Bag 7902
Wellington 6242
Country 6723 0
New Zealand
Phone 6723 0
+64 (04)805 0147
Fax 6723 0
Email 6723 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized controlled trial of the effect of regular paracetamol on influenza infection.2016https://dx.doi.org/10.1111/resp.12685
N.B. These documents automatically identified may not have been verified by the study sponsor.