Clinical trial comparing the effect of Acetaminophen and Ibuprofen on the duration of influenza viral shedding in young children (Pilot study) - Acetaminophen and Ibuprofen on duration of influenza shedding (pilot)

• Conditions: Influenza in children [positive rapid diagnostic test (QuickVue influenza test)confirmed by influenza PCR]Infants and young children shed the influenza virus for longer periods than adults, duration of shedding occurring anywhere from up to 2-3 weeks as opposed to young adults who shed the virus for less than a week when serial viral cultures are performed.

• Registration Number: EUCTR2006-001611-30-GB
• Lead Sponsor: Hammersmith Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Any infant or child presenting to the paediatric ambulatory unit with a history of one or more of the following conditions for less than 3 days (72hours) is eligible for recruitment.
•Acute upper respiratory tract infections which include: colds, sinusitis,
pharyngitis (red sore-throat), tonsillitis (inflamed tonsils) and acute otitis
media
•Acute lower respiratory tract illnesses which include: croup, tracheitis,
bronchiolitis (wheeze under the age of 12-months), viral induced wheeze,
asthma (history of atopy) and pneumonia
•Any seizure: febrile and non-febrile
•Any acute febrile gastroenteritis without rebound tenderness or guarding
•Apnoea or any life-threatening event in infants under 12-months of age
•Any acute febrile illness (temperature = 38.0C).
•Parents should be fluent and literate in English
•Parents are able and willing to adhere to the procedures stated in the
protocol

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Inclusion criteria not met
•Collection of a nasal secretion sample is medically contraindicated, e.g.,
child with recent nasopharyngeal surgery
•Those with a fever and a known non-respiratory viral illness.
•Children requiring admission
•Allergic to ibuprofen or paracetamol
•Any underlying chronic illness which requires the long term use of
antipyretics and other analgesics such as acetaminophen and NSAID.
•High risk medical conditions for influenza except for asthma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if there is a difference in the duration of influenza virus shedding in children with influenza who are given acetaminophen compared to those given ibuprofen<br><br>;Secondary Objective: To determine if there is a difference in the time to alleviation of symptoms in children with influenza who are given acetaminophen or ibuprofen<br><br>;Primary end point(s): Primary endpoint <br>Measures<br>•Duration of viral shedding<br>•Sequential viral loads<br>