30 July 2026
The international PediCAP trial in children with severe community-acquired pneumonia shows that, following clinical improvement, switching from intravenous to oral antibiotics is as effective as intravenous-only treatment. On average, hospital stay was shortened by just under one day.
Pneumonia is the leading infectious cause of death in children worldwide. More than 700,000 children under the age of five die from it each year, particularly in resource-constrained settings. The PediCAP trial compared the WHO standard of 5 days of intravenous antibiotic treatment with alternative strategies allowing an earlier step-down to oral antibiotics.
Trial conducted in five countries
The randomised trial enrolled 1,101 children aged 2 months to 6 years at 13 hospitals in Africa. They had severe community-acquired pneumonia without complicating factors. After at least 24 h of intravenous treatment, three strategies were compared: step-down to oral amoxicillin upon clinical improvement, step-down to oral amoxicillin-clavulanate (co-amoxiclav), and 5-day, fixed-duration, intravenous-only treatment.
In the oral step-down groups, total treatment duration (4-8 days) was also investigated. The primary outcome was all-cause hospital readmission or death by day 28.
Oral treatment as effective as intravenous treatment
The primary outcome occurred in 5.6% (amoxicillin), 6.9% (co-amoxiclav) and 6.3% (intravenous only). Both oral step-down strategies were non-inferior to the intravenous-only strategy. There was no evidence that co-amoxiclav was superior to amoxicillin. Given its availability and affordability, the findings support amoxicillin as the preferred oral step-down option.
Shorter total treatment durations (4-7 days) were also non-inferior to the 8-day group. Around two-thirds of children had switched to oral treatment after 3 days. On average, hospital stay was 0.9 days shorter than with intravenous-only treatment. There was no evidence of consistent differences in adverse events.

Prof. Julia Bielicki, co-first author
Clinical Professor of Paediatric Clinical Pharmacology at the University of Basel, Head of the Paediatric Research Centre and Senior Consultant in Infectious Diseases, Vaccinology and Migration Medicine at University Children’s Hospital Basel (UKBB), as well as DKF Research Group Leader
(Source: City St George’s, University of London)
Significance of the findings
The trial supports an early step-down to oral amoxicillin in children whose condition improves after initial intravenous treatment. This could shorten hospital stays, with relevant benefits for families and health systems, particularly in resource-constrained settings.
The findings do not apply to critically ill children or children with complicating factors. As clinicians were allowed to modify treatment when clinically indicated, the pragmatic trial reflects clinical practice and provides a basis for reviewing international guidelines.

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Oral step-down, optimal drug, and total duration of antibiotic treatment in African children hospitalised with severe community-acquired pneumonia
Principal Investigator
Prof. Mike Sharland, City & St George’s, University of London
Study Design
International, multicenter, open-label, randomized controlled factorial trial with superiority and non-inferiority comparisons
Study Sites
13 hospitals in South Africa, Uganda, Zambia, Zimbabwe, and Mozambique
Number of Study Participants
1,101 children aged two months to six years
Project duration
5 years, March 2019 to March 2024
Funding
European and Developing Countries Clinical Trials Partnership (EDCTP2), supported by the European Union