Lower Respiratory Tract Infection in children aged 6 months - 12 years Respiratory
Conditions
Interventions
Amoxicillin 50mg/kg/24 hours (in divided doses for 7 days) or placebo
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 26/07/2016: 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) Previous primary outcome measure: Duration of moderately bad symptoms (from validated symptom diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/07/2016: 1. Symptom severity (days 2-4) (measured as with the 1y outcome); duration of symptoms until little or no problem (measured as with the primary outcome); re-consultation with non-resolving, new or worsening symptoms (from structured review of medical records); complications (from structured review of medical records) 2. Health-related quality of life will be measured by proxy methods in which the EuroQoL (EQ5D 5Y) will be completed by patients or carers (on days 1, 3, 7, 14, 21, 28) 3. Follow-up (at 1 month): measure lung function (if aged 6+; using PEFR meter) Previous secondary outcome measures from 23/03/2016 to 26/07/2016: 1. Symptom severity (days 2-4); the development of new or worsening symptoms; complications 2. Health-related quality of life will be measured by proxy methods in which the Pediatric Quality of Life Inventory (PedsQL) and EuroQoL (EQ5D) will be completed by patients or carers (on days 1, 3, 7, 14, 21, 28) 3. Follow-up (at 1 month): measure lung function (if aged 6+) Original secondary outcome measures: 1. Symptom severity (days 2-4); the development of new or worsening symptoms; complications 2. Health-related quality of life will be measured by proxy methods in which The Health Utilities Index (HUI-Mark III) and EuroQoL (EQ5D) will be completed by patients or carers (on days 1, 3, 7, 14, 21, 28) 3. Follow-up (at 1 month): measure lung function (if aged 6+) | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactNatalie Thompson
Outcome results
None listed