PediCAP: “Impact of duration of antibiotic therapy and of oral step-down to amoxicillin or co-amoxiclav on effectiveness, safety and selection of antimicrobial resistance in severe and very severe childhood community-acquired pneumonia (CAP): a randomised controlled trial (PediCAP Trial)”
PediCAP is a research project funded by EDCTP2 programme, which aims to promote clinical trial partnerships between European and Sub-Saharan African countries.
Coordinated by Penta, the overarching objective of PediCAP is to optimise antibiotic treatment for children aged 3 months to 10 years hospitalized with severe/very severe community-acquired pneumonia in South Africa, Uganda, Zambia and Zimbabwe by answering the following questions:
1) Is the rate of clinical cure superior with co-amoxiclav vs amoxicillin oral step-down therapy?
2) What is the optimal antibiotic treatment duration that achieves high rates of clinical cure whilst minimizing length of hospital stay, toxicity and antimicrobial resistance?
3) Does this optimal duration vary by key characteristics, such as age or severity, suggesting that antibiotic duration should be personalised to specific subgroups?
Patients will be recruited into the trial from five centres across these Sub-Saharan countries over 2 years. All participants will be followed for 4 weeks after randomisation. Moreover, the project will include PK, microbiology and health economics substudies, as well as activities aimed at capacity building, networking and patient involvement.
PediCAP is a collaboration between Penta and partners in Uganda, South Africa, Zambia, Zimbabwe, Belgium, Switzerland and the UK, bringing together different paediatric groups into a new consortium. Several members have a long and successful history of collaborating on PENTA/MRC trials in HIV-infected children/adolescents, whose results have been incorporated into WHO HIV guidelines. They also have substantial experience of research in other severe childhood illnesses.