Do young children need antibiotics when they have a mild or moderate chest infection when they go to a primary care clinician?

Phase 4

Completed

• Conditions: ower Respiratory Tract Infection in children aged 6 months - 12 years; Respiratory

• Registration Number: ISRCTN79914298
• Lead Sponsor: niversity of Southampton (UK)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34562391/ (added 27/09/2021) 2023 Results article in https://doi.org/10.3310/dgbv3199 (added 13/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-21
• Study Completion: 2020-04-17
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

Children between 6 months and 12 years old presenting with an acute lower respiratory infection (LRTI), defined as an acute cough as the predominant symptom, judged by the GP to be infective in origin, lasting <21 days, and with other symptoms or signs localising to the lower tract (shortness of breath, sputum, pain)

Added 26/07/2016:
Individuals who are allergic to penicillin, who cannot be randomised (e.g. with known immune deficiency, or where a complication such as pneumonia is suspected on clinical grounds), or are unwilling to be randomised, are still eligible for the observational study where the same outcomes will be measured.

Exclusion Criteria

1. The cough is judged by the clinician to have a non-infectious aetiology (e.g., hayfever or non-infective exacerbation of asthma) or almost certain viral aetiology (croup, where antibiotics are not commonly prescribed)
2. Immune-compromised
3. Antibiotic use in previous 30 days
4. For the trial, suspected pneumonia based on clinical examination or being very severely ill as judged by the GP is an exclusion (but such children can still enter the observational study which will allow for an assessment of trial participants’ external validity)
5. Only one child from each household will be recruited

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 26/07/2016:<br>Duration of moderately bad chest infection symptoms (from validated symptom diary; where the diary is not returned using a brief questionnaire completed either by post or by phone)<br><br>Previous primary outcome measure:<br>Duration of moderately bad symptoms (from validated symptom diary)