Antibiotics for chest infections in children consulting with the GP

Phase 1

• Conditions: Respiratory tract infections in children aged between 6 months and 12 years; MedDRA version: 20.1Level: LLTClassification code 10066740Term: Acute respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10024968Term: Lower respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002455-97-GB
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-24
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 938

Inclusion Criteria

Children between 6 months and twelve 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 (any of: a systemic symptom (diarrhoea, fever, raised temperature), coryza, sputum production, wheezing, sore throat, earache), lasting <21 days, and with other symptoms or signs localising to the lower tract (shortness of breath, sputum - or more likely in this age group audible secretions suggesting sputum), Parent/guardian willing and able to be contacted for follow up and complete symptom diary for up to 28 days.

Are the trial subjects under 18? yes
Number of subjects for this age range: 938
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The cough is judged by the clinician to have a non-infectious aetiology (e.g. hayfever or asthma) or almost certain viral aetiology (croup, where antibiotics are not commonly prescribed); immune-compromised; and antibiotic use in previous 30 days. 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. In addition only one child from each household will be recruited. Additionally children will be eligible for trial but eligible for cohort study if the child is immune-compromised, has a history of antibiotic use in previous 30 days, has a clinical diagnosis of pneumonia, has had previous pneumonia, has focal rales, has a low oxygen saturation (<92%), has severe tachypnoea (clinician judged), has Severe Asthma requiring long-term maintenance oral steroids (as defined in the British Thoracic Society Step 5).

Study & Design

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