Lascufloxacin switch therapy versus ampicillin/sulbactam for older patients with community-acquired pneumonia in Japan (STEP study): a study protocol for a multicentre open-label randomised controlled non-inferiority trial.

INTRODUCTION

Community-acquired pneumonia (CAP) is a major cause of morbidity and mortality in older adults in Japan. Prolonged hospitalisation accelerates functional decline, promotes the progression of frailty and increases the need for long-term care. An early switch from intravenous to oral antibiotics helps achieve clinical outcomes comparable to those of continued intravenous therapy while shortening hospital stays. For older adults with frailty, avoiding unnecessary hospitalisation may help prevent further deterioration of functional status. Demonstrating non-inferiority of oral antibiotics for clinical cure would help clinicians recommend the use of switch therapy to shorten hospital stay and improve functional outcomes in this high-risk population. This study aimed to evaluate the non-inferiority of lascufloxacin switch therapy to intravenous ampicillin/sulbactam in older adults with frailty and CAP.

METHODS AND ANALYSIS: This multicentre randomised open-label trial enrols older adults with mild to moderate CAP and frailty according to the Frailty Screening Index. Participants will be randomised using minimisation with the Age, Dehydration, Respiratory Failure, Orientation Disturbance and Low Blood Pressure score and Frailty Screening Index as allocation factors to receive either lascufloxacin switch therapy or ampicillin/sulbactam intravenous. The primary endpoint is the clinical cure rate at the test of cure. Secondary endpoints include early clinical response, end-of-treatment response, hospital stay, medical costs, clinical stability, 30-day mortality or recurrence and microbiological outcomes. The planned sample size is 80 patients per group.

ETHICS AND DISSEMINATION: This study was approved by the Certified Review Board of Nagasaki University, Japan. These results will be disseminated through scientific presentations and publications.

TRIAL REGISTRATION NUMBER: jRCTs071250072 (https://jrct.mhlw.go.jp/en-latest-detail/jRCTs071250072).