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 two months to six 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 two months to six 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?
PediCAP part A study has closed to recruitment as it has successfully hit the desired target sample size of 1,100 babies on 14th Aug 2023. PediCAP part B study was opened at 4 sites in total (included South Africa, Zambia, Zimbabwe and Uganda) from end of May 2023 onwards. The first site opened to start recruitment for PediCAP-B was Chris Hani in South Africa on 26th May 2023.
We anticipate that the recruitment to PediCAP-B will end at the earliest towards the end of Jan 2024 and estimate the LPLV date would fall at the end of Feb 2024.
Who is funding the study?
The trial is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), a collaboration between countries in Europe and sub-Saharan Africa, supported by the European Union, to improve the health of Africans by doing important research trials
When is it taking place?
This trial began in March 2019 and is expected to run until March 2024.
Where is it taking place?
Five sites in South Africa, Uganda, Zambia, Zimbabwe and Mozambique.
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.