{
  "abstract": "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)",
  "authors": [
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Kazuaki Takeda"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan",
        "Department of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"
      ],
      "name": "Takahiro Takazono"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Nobuyuki Ashizawa"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Masataka Yoshida"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan",
        "Infectious Diseases Experts Training Center, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Shotaro Ide"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan",
        "Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"
      ],
      "name": "Naoki Iwanaga"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan",
        "Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Katsuji Hirano"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan",
        "Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Naoki Hosogaya"
    },
    {
      "affiliations": [
        "Respiratory Medicine and Infectious Diseases, Oita University Faculty Of Medicine, Yufu, Japan",
        "Research Center for Global and Local Infectious Diseases, Oita University, Oita, Japan"
      ],
      "name": "Kosaku Komiya"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"
      ],
      "name": "Koichi Izumikawa"
    },
    {
      "affiliations": [
        "Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan"
      ],
      "name": "Katsunori Yanagihara"
    },
    {
      "affiliations": [
        "Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan",
        "Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"
      ],
      "name": "Hiroshi Mukae"
    }
  ],
  "title": "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",
  "uid": "35bea80a-12ef-5bb6-b9ed-a7de50ed8f7f"
}