Children hospitalized with severe pneumonia can safely switch from injectable to oral antibiotics once they begin to recover, allowing many to return home sooner and complete treatment outside the hospital, according to a Jul. 23 international clinical trial led by researchers from City St George's, University of London, UCL Innovative Clinical Trials Unit, and partners across Africa and Europe. The results were published in The Lancet.
Pneumonia remains one of the leading infectious killers of children worldwide, particularly in low- and middle-income countries. Current World Health Organization guidelines recommend five days of injectable antibiotics for children hospitalized with severe community-acquired pneumonia, which often requires them to stay in hospital even after substantial improvement.
The PediCAP trial enrolled 1,101 children aged two months to six years with community-acquired pneumonia that was severe enough for hospitalization. Thirteen hospitals across South Africa, Uganda, Zambia, Zimbabwe and Mozambique participated in the study. All participants began treatment with a WHO-recommended injectable antibiotic; some were assigned to switch to either oral amoxicillin or oral amoxicillin-clavulanate upon improvement as confirmed by a healthcare worker. These groups were compared against those who received the full five-day course of injectable antibiotics.
Children who switched early to oral antibiotics recovered as well as those who remained on injectables for five days. Hospital readmission or death within 28 days occurred at similar rates: 6% for oral amoxicillin, 7% for oral amoxicillin-clavulanate and 6% for injectables. Researchers also found that standard amoxicillin performed as well as the broader-spectrum antibiotic amoxicillin-clavulanate.
A comparison of different total durations showed that four or five days of antibiotics was as effective as longer courses lasting seven or eight days. Children switching early left hospital about one day earlier than those completing all treatment via injection.
Dr. Michelle Clements, Principal Statistician at UCL Innovative Clinical Trials Unit and co-lead author, said: "PediCAP is the first large-scale study to use our innovative multi-arm trial design to evaluate different antibiotics and treatment durations at the same time. Rather than simply comparing one short course with one longer course, this approach allowed us to establish that the shortest studied treatment strategy was effective and safe, while also helping us understand the relationship between treatment length and effect." Clements added: "By generating robust evidence more efficiently, this trial design has helped answer questions that we hope will support changes to global treatment guidelines and improve care for millions of children with pneumonia worldwide."
