Impact of oral step-down to amoxicillin or co-amoxiclav and of duration of antibiotic therapy on effectiveness, safety and selection of antibiotic resistance in severe childhood community-acquired pneumonia (CAP): a randomised controlled trial
What is the best way to treat children aged 2 months to 6 years who have pneumonia that has developed at home and is so serious that they need to be treated in hospital?
What is this study about?
In the PediCAP trial, we aim to answer all of the following questions to work out the best way to treat children aged 2 months to 6 years who have pneumonia (a chest infection) that has developed at home and is so serious that they need to be treated in hospital:
- Is the rate of clinical cure better if children move from injectable antibiotics to oral co-amoxiclav or oral amoxicillin antibiotics once they are well enough to take drugs by mouth, and how does this compare to staying on injectable antibiotics?
- What is the best duration of antibiotic treatment for children that gives good rates of clinical cure while reducing how long they have to stay in hospital, the side effects they experience and the presence of other antibiotic-resistant bacteria?
- Does this best duration depend on other factors, such as age, having been exposed to HIV, having malnutrition or how serious the chest infection is, suggesting that how long children get antibiotics for should be vary based on these risk factors?
- What ratio of amoxicillin to clavulanate should be used in co-amoxiclav for children?
Who is funding the study?
European and Developing Countries Clinical Trials Partnership (EDCTP)
When is it taking place?
1 March 2019 – 1 March 2024
Where is it taking place?
5 sites in South Africa, Uganda, Zambia and Zimbabwe
Who is included?
Children aged 2 months to 6 years inclusive and weighing >=3kg and <30kg hospitalised with severe community acquired pneumonia and with C-reactive protein >10 mg/l on a semi-quantitative point-of-care test at screening, who are about to start or who have started intravenous antibiotics for severe Community Acquired Pneumonia
PediCAP recruits its first participant
07 Dec 2020