A trial of young children in sub-Saharan Africa with severe pneumonia found that switching from intravenous (IV) to oral antibiotics after clinical improvement is safe and effective, a finding that could allow for earlier release from the hospital, researchers reported last week in The Lancet.

Although severe pneumonia is not as deadly as it once was in children, it’s still a leading cause of childhood mortality and hospitalization worldwide, particularly in resource-limited regions. Current World Health Organization guidelines for severe childhood pneumonia advise hospitalization and five days on IV antibiotics, with some children required to stay in the hospital even after substantial improvement. Milder cases are treated with three to five days of oral antibiotics.

To investigate whether a step-down from IV to oral antibiotics after clinical improvement is as effective as IV-only treatment for severe cases, an international team of investigators randomly assigned 1,101 children aged 2 months to 6 years who had severe community-acquired pneumonia (CAP) at 13 African hospitals to switch from IV to oral antibiotics when their condition had improved or receive the full five-day IV treatment.

The study, reporting on outcomes of the PediCAP trial, is one of several to assess whether shorter antibiotic treatments for pediatric pneumonia are as effective longer treatments. But few have looked specifically at children hospitalized with severe pneumonia.

“Strategies are needed that will adequately treat CAP and minimise exposure to the hospital environment, such as intravenous-to-oral step-down in patients showing clinical improvement after short intravenous treatment,” the study authors wrote.

The primary outcome of the PediCAP trial was hospital readmission or all-cause death at 28 days. The non-inferiority margin was 10%. Investigators also compared whether oral amoxicillin or broader-spectrum amoxicillin-clavulanate is a preferable step-down option and assessed how well children fared with different duration of oral antibiotics (ranging from four to eight days).

Children in the two oral step-down groups received a median of two days of IV antibiotics. Rates of hospital readmission or death were 5.6% in the children who switched to amoxicillin, 6.9% in the group that switched to amoxicillin-clavulanate, and 6.3% in the IV-only group, indicating that both oral step-down strategies were non-inferior to the IV-only strategy. Adverse events were similar in all three treatment groups.

This simple change could help children get back to their families sooner, reduce pressure on busy hospitals, lower healthcare costs and avoid sometimes catastrophic financial impacts on families from lost caregiver earnings.

There was no evidence that amoxicillin-clavulanate was superior to amoxicillin, which the authors say is important because amoxicillin is cheaper and widely available. 

Children in both step-down groups spent a day less in the hospital than those in the IV-only group (5.5 versus 6.5 days). The results also showed that antibiotic courses of four to five days fared were as effective as seven to eight days.

“This simple change could help children get back to their families sooner, reduce pressure on busy hospitals, lower healthcare costs and avoid sometimes catastrophic financial impacts on families from lost caregiver earnings,” first study author Julia Bielicki, PhD, MPH, a professor of pediatric infectious disease at City of St. Georges, University of London, said in a university press release.