A randomised placebo-controlled trial to investigate the use of paracetamol in the treatment of influenza

A randomised double-blind placebo-controlled trial to investigate whether paracetamol lengthens the duration of viral shedding in the treatment of patients with influenza

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000497909

Enrollment

Registered

2011-05-12

Start date

2011-07-18

Completion date

2012-09-24

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Paracetamol, oral, coated tablet (1g four times daily for 5 days)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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

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.

Outcome results