PediCAP pneumonia trial completes recruitment

14 Sep 2023

The PediCAP team is pleased to report that they have successfully recruited the 1,100 patients required for the study’s main trial.

PediCAP is an innovative clinical trial which uses the novel DURATIONS design led by the MRC Clinical Trials Unit at UCL to study the optimal drug, dose and duration of oral step-down antibiotics for children admitted to hospital with severe community-acquired pneumonia. Children included in the trial are aged between 2 months and 6 years and have been recruited from hospitals in Mozambique, South Africa, Uganda, Zambia and Zimbabwe.

Pneumonia affects children and families globally and is one of the leading causes of death in children under 5, especially in Southern Asia and Africa. There is an urgent need for effective and simple treatment options for children with pneumonia. Though antibiotics are key to managing childhood pneumonia, current WHO recommendations are that children hospitalised for severe community-acquired pneumonia only be given antibiotics intravenously, which means that children must remain hospitalised for the entire duration of the treatment course. This affects the wellbeing of children and their families and places a burden on healthcare facilities. It also increases the risk of antimicrobial resistance and hospital-acquired infections.

PediCAP evaluates the safety and effectiveness of an early step-down from intravenous to oral antibiotics, comparing different durations of oral amoxicillin to co-amoxiclav. Researchers hope this could establish a more convenient and potentially equally effective alternative to the WHO intravenous treatment recommendations.

This significant milestone brings PediCAP A results closer, with the main clinical outcome results of the trial supported by planned pharmacokinetic, microbiology, and health economic analyses. The PediCAP B trial, which compares other novel formulations of co-amoxicillin is still recruiting and is planned to complete in 2024.

PediCAP is funded by the EDCTP2 programme supported by the European Union (grant number RIA2017MC – 2023 – PediCAP) and is coordinated by Fondazione Penta ETS (Italy). Sandoz, a global generic and biosimilar medicines company based in Switzerland, donated a novel paediatric dispersible tablet formulation of co-amoxiclav 7:1 to support PediCAP’s main trial.

Further information: