The Benefit and Harm of Fever Suppression by Antipyretics in Influenza

NCT01891084 | Completed Phase 4

• 1 other identifier: DKMI003.4
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential benefits and risks of antipyretics use in naturally occurring influenza virus infections in humans.

Conditions

Influenza

Keywords

Influenza; Antipyretics; Fever

Outcome Measures

Primary Outcomes (2)

• Time from recruitment to illness resolution, defined as the time when fever and at least nine out of the ten influenza symptoms had subsided (graded as 0 by the patient) for a period of 24 hours.

  Self-recording of temperature twice daily for ten days (D1-D10) will be performed and recorded using a standard tympanic thermometer provided for free to each participant. Participants will also keep symptom diary twice daily for 10 days (from D1-D10), using 4-point scale of 0, 1, 2, or 3 for absent, mild, moderate, or severe symptoms respectively. Mild symptoms are easily tolerated and do not interfere with any usual activities; moderate symptoms interfere with usual activities; Severe symptoms are such that the individual cannot carry out usual activities. Ten common influenza symptoms (including feverishness, chills, cough, rhinorrhea, sore throat, general fatigue, headache, myalgia/arthralgia, vomiting, and diarrhea) will be recorded.

  10 days

• Time from recruitment to cessation of viral shedding, defined as the time when no virus is detected by RT-PCR from both nasal and throat swabs.

  Nasal and throat swabs will be collected on D1, D4, D7 and D10 for viral identification and subtyping by viral culture, and viral load detection and quantification by quantitative RT-PCR.

  10 days

Secondary Outcomes (7)

• Time to cessation of illness and viral shedding from illness onset

  10 days

• The duration of individual symptoms

  10 days

• The incidence of secondary complications

  10 days

• The use of backup NSAID provided

  10 days

• Quality of life

  10 days

Study Arms (2)

Paracetamol

ACTIVE COMPARATOR

Paracetamol 1 tablet (500mg) four times daily. For a maximum period of 5 days if the patient is still having fever. When required, participants may take up to 2 tablets (1gm) in each dose. Precautionary statement (Do not exceed 8 tablets daily) will be printed on the dispensary label to avoid overdose. Backup NSAID ibuprofen 200mg orally every 8 hourly will also be provided to all participants, which can be taken when necessary (PRN) if the participant finds the fever intolerable.

Drug: Paracetamol; Drug: Backup NSAID ibuprofen

Placebo

PLACEBO COMPARATOR

(Identical-looking) Placebo 1 tablet four times daily. For a maximum period of 5 days if the patient is still having fever. When required, participants may take up to 2 tablets in each dose. Precautionary statement (Do not exceed 8 tablets daily) will be printed on the dispensary label to avoid overdose. Backup NSAID ibuprofen 200mg orally every 8 hourly will also be provided to all participants, which can be taken when necessary (PRN) if the participant finds the fever intolerable

Drug: Placebo; Drug: Backup NSAID ibuprofen

Interventions

Paracetamol DRUG

Paracetamol 1 tablet (500mg) four times daily. For a maximum period of 5 days if the patient is still having fever. When required, participants may take up to 2 tablets (1gm) in each dose.

Also known as: Acetaminophen

Paracetamol

Placebo DRUG

(Identical-looking) Placebo 1 tablet four times daily. For a maximum period of 5 days if the patient is still having fever. When required, participants may take up to 2 tablets in each dose.

Placebo

Backup NSAID ibuprofen DRUG

Backup NSAID ibuprofen 200mg orally every 8 hourly will also be provided to all participants, which can be taken when necessary (PRN) if the participant finds the fever intolerable.

Also known as: ibuprofen

Paracetamol; Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 18-30
• Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) within 48 hours of illness onset
• being tested positive with a QuickVue rapid influenza test

You may not qualify if:

• Allergic to paracetamol or any other antipyretics
• Have any underlying immunocompromized condition or be receiving immunosuppressive agents.
• Have any history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University Health Service, The Hong Kong Polytechnic University

Hong Kong, Hksar, China

Location

MeSH Terms

Conditions

Influenza, Human; Fever

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Dennis KM Ip, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 2, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CN (1)