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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)

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001611-30-GB
Enrollment
15
Registered
2006-04-03
Start date
2006-08-22
Completion date
Unknown
Last updated
2012-03-19

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

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.

Interventions

Trade Name: Paracetamol (acetaminophen) Pharmaceutical Form: Oral suspension Trade Name: Ibuprofen (Nurofen) Pharmaceutical Form: Oral suspension

Sponsors

Hammersmith Hospital NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 ;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 ;Primary end point(s): Primary endpoint Measures • Duration of viral shedding • Sequential viral loads

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026