What this Trial Is About

Researchers are evaluating whether prednisolone, an anti-inflammatory drug, can effectively treat moderate to severe respiratory tract infections in adults admitted to the hospital. This Phase 3 trial also aims to assess the safety of prednisolone by comparing it to a placebo. The study focuses on whether prednisolone reduces the number of patients who develop sepsis or die within 30 days, as well as monitoring for any serious adverse events. Participants will be randomly assigned to receive either prednisolone 30 mg or a placebo tablet once daily for five days. The trial uses an adaptive platform design to efficiently test treatments and may adjust treatment allocation based on ongoing results. All participants will continue to receive usual care alongside the trial medication. The study will be conducted in emergency departments and hospital wards in Hong Kong, enrolling approximately 1300 adults. During the 30-day follow-up period, participants will complete daily symptom diaries and have telephone check-ins. Researchers will monitor health outcomes including the occurrence of sepsis, mortality, and any severe adverse events up to 30 days after treatment begins. This trial’s findings could help improve treatment strategies for respiratory infections worldwide and reduce serious complications and healthcare costs.

PREDICATE Trial For Respiratory Tract Infections