CAP-IT
Research type
Research Study
Full title
Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia (CAP): a randomised controlled trial.
IRAS ID
196728
Contact name
Mike Sharland
Contact email
Sponsor organisation
Medical Research Council Clinical Trials Unit at UCL
Eudract number
2016-000809-36
ISRCTN Number
ISRCTN76888927
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Pneumonia (an infection of the lungs) is one of most common infections in young children worldwide. Antibiotics are very commonly prescribed to children for possible pneumonia.
We know that treatment with antibiotics can lead to changes in the bacteria carried by the person taking them, making the bacteria become more resistant to the effect of the antibiotics. These resistant bacteria can subsequently cause infections which are more difficult to treat.
The amount of antibiotic (dose) and the number of days of treatment (duration) is likely to have an effect on the development of resistant bacteria in individual patients. Currently we do not know which antibiotic treatment duration and dose are optimal for treating childhood pneumonia. Also the relationship between dose, duration and the development of resistant bacteria in the nose and gut (two preferred places where bacteria live) is not understood.
Amoxicillin is the antibiotic most commonly used for pneumonia in children. The CAP-IT trial will look at whether lower doses and shorter duration of amoxicillin are as good at treating pneumonia as higher doses and longer duration of treatment.
Parents or carers of children will be asked to join the study if the child has pneumonia and will be treated with amoxicillin. Children who are discharged immediately from the emergency department can join the study straight away. Children who need a short period of intravenous treatment or observation on the ward can join the study after up to 48 hours of inpatient therapy.
CAP-IT will be conducted in NHS Paediatric Emergency Departments (PEDs) and inpatient wards throughout the UK. 2400 children will be recruited in total. Each child will be followed up for 4 weeks via a symptom diary, weekly telephone calls with the research nurse and a final visit at hospital 4 weeks after entering the trial.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0831
Date of REC Opinion
30 Jun 2016
REC opinion
Further Information Favourable Opinion