{
  "abstract": "Introduction Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children. In East Asia, the prevalence of macrolide-resistant MP (MRMP) has surged, leading to treatment failures and prolonged illness. While doxycycline is an effective alternative, its use in young children has historically been limited due to concerns about tooth discolouration. This study aims to evaluate the efficacy and safety of doxycycline compared with azithromycin as a first-line treatment for children with pneumonia suspected of MRMP infection.Methods and analysis This is a multicentre, randomised, open-label, parallel-group superiority trial conducted at 14 tertiary hospitals in South Korea. A total of 208 children (aged 3–17 years) with pneumonia and confirmed or suspected MP infection will be randomised 1:1 to receive either doxycycline (4 mg/kg/day in two divided doses for 7–14 days) or azithromycin (10 mg/kg on day 1, then 5 mg/kg on days 2–5) ( online supplemental tables 1 and 2). Randomisation will be stratified by age (3–7 years vs 8–17 years). A standardised ‘rescue therapy’ protocol ensures patient safety by allowing control group patients to switch to doxycycline if no clinical improvement is observed within 48–72 hours. The primary outcome is the defervescence rate within 72 hours after randomisation. Secondary outcomes include treatment failure rate, length of hospital stay, symptom duration and adverse events. Safety assessment will specifically include tooth discolouration evaluation at Day 28, focused on children aged <8 years. Efficacy will be analysed using the intention-to-treat principle.Ethics and dissemination This study has been approved by the Institutional Review Boards (IRB) of all participating centres. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from children aged 7 years and older. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT07306234.",
  "authors": [
    {
      "affiliations": [
        "Korea University Anam Hospital, Department of Pediatrics, Korea University College of Medicine, Seongbuk-gu, Republic of Korea"
      ],
      "name": "Youn Young Choi"
    },
    {
      "affiliations": [
        "Korea University Anam Hospital, Department of Pediatrics, Korea University College of Medicine, Seongbuk-gu, Republic of Korea"
      ],
      "name": "Changmin Kang"
    },
    {
      "affiliations": [
        "Korea University Anam Hospital, Department of Pediatrics, Korea University College of Medicine, Seongbuk-gu, Republic of Korea"
      ],
      "name": "Young June Choe"
    },
    {
      "affiliations": [
        "Korea University Anam Hospital, Department of Pediatrics, Korea University College of Medicine, Seongbuk-gu, Republic of Korea"
      ],
      "name": "Young Yoo"
    },
    {
      "affiliations": [
        "Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Suwon-si, Republic of Korea"
      ],
      "name": "Areum Shin"
    },
    {
      "affiliations": [
        "Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Suwon-si, Republic of Korea"
      ],
      "name": "Doo Ri Kim"
    },
    {
      "affiliations": [
        "Seoul National University Children’s Hospital, Department of Pediatrics, Seoul National University College of Medicine, Jongno-gu, Republic of Korea"
      ],
      "name": "Bin Ahn"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Republic of Korea"
      ],
      "name": "Byung Wook Eun"
    },
    {
      "affiliations": [
        "Chosun University Hospital, Department of Pediatrics, Chosun University College of Medicine, Gwangju, Republic of Korea"
      ],
      "name": "Gahee Kim"
    },
    {
      "affiliations": [
        "College of Medicine, Department of Pediatrics, The Catholic University of Korea Seoul St Mary’s Hospital, Seocho-gu, Republic of Korea"
      ],
      "name": "Hyun-Mi Kang"
    },
    {
      "affiliations": [
        "College of Medicine, Department of Pediatrics, The Catholic University of Korea Seoul St Mary’s Hospital, Seocho-gu, Republic of Korea"
      ],
      "name": "Ye Ji Kim"
    },
    {
      "affiliations": [
        "College of Medicine, Department of Pediatrics, The Catholic University of Korea Seoul St Mary’s Hospital, Seocho-gu, Republic of Korea"
      ],
      "name": "Yoon Kyung Cho"
    },
    {
      "affiliations": [
        "Seoul National University Bundang Hospital, Department of Pediatrics, Seoul National University College of Medicine, Jongno-gu, Republic of Korea"
      ],
      "name": "Hyunju Lee"
    },
    {
      "affiliations": [
        "Seoul National University Bundang Hospital, Department of Pediatrics, Seoul National University College of Medicine, Jongno-gu, Republic of Korea"
      ],
      "name": "Ye Kyung Kim"
    },
    {
      "affiliations": [
        "Jeju National University School of Medicine, Department of Pediatrics, Jeju National University Hospital, Jeju-si, Republic of Korea"
      ],
      "name": "Jae Hong Choi"
    },
    {
      "affiliations": [
        "Seoul National University Children’s Hospital, Department of Pediatrics, Seoul National University College of Medicine, Jongno-gu, Republic of Korea",
        "College of Medicine, Department of Pediatrics, The Catholic University of Korea Seoul St Mary’s Hospital, Seocho-gu, Republic of Korea"
      ],
      "name": "Ki Wook Yun"
    },
    {
      "affiliations": [
        "Pusan National University Children’s Hospital, Department of Pediatrics, Pusan National University School of Medicine, Busan, Republic of Korea"
      ],
      "name": "Kyo Jin Jo"
    },
    {
      "affiliations": [
        "Gyeongsang National University Changwon Hospital, Department of Pediatrics, Gyeongsang National University College of Medicine, Jinju-si, Republic of Korea"
      ],
      "name": "Kyung-Ran Kim"
    },
    {
      "affiliations": [
        "CHA Bundang Medical Center, Department of Pediatrics, CHA University School of Medicine, Pocheon-si, Republic of Korea"
      ],
      "name": "Taek Jin Lee"
    },
    {
      "affiliations": [
        "College of Medicine, Department of Pediatrics, The Catholic University of Korea Eunpyeong St Mary’s Hospital, Eunpyeong-gu, Republic of Korea"
      ],
      "name": "Ui Yoon Choi"
    },
    {
      "affiliations": [
        "Korea University Guro Hospital, Department of Pediatrics, Korea University College of Medicine, Seongbuk-gu, Republic of Korea"
      ],
      "name": "Yoon Sun Yoon"
    },
    {
      "affiliations": [
        "Korea Disease Control and Prevention Agency, Division of Clinical Research, National Institute of Health, Seoul, Republic of Korea"
      ],
      "name": "Jungyeon Kim"
    },
    {
      "affiliations": [
        "Korea Disease Control and Prevention Agency, Division of Clinical Research, National Institute of Health, Rome, Italy"
      ],
      "name": "Mi Sun Kang"
    },
    {
      "affiliations": [
        "Korea Disease Control and Prevention Agency, Division of Clinical Research, National Institute of Health, Osong, Republic of Korea"
      ],
      "name": "Seon Kyeong Park"
    },
    {
      "affiliations": [
        "Korea Disease Control and Prevention Agency, Division of Clinical Research, National Institute of Health, Osong, Republic of Korea"
      ],
      "name": "Woo Mi Yang"
    },
    {
      "affiliations": [
        "MW Division, Dt&CRO, Seoul, Republic of Korea"
      ],
      "name": "Sunyoung Lee"
    }
  ],
  "title": "Efficacy and safety of Doxycycline versus Macrolides for Mycoplasma pneumoniae INfectiOn in Children (DOMINO): a protocol for a multicentre, randomised, open-label, superiority trial",
  "uid": "323824fd-5ee0-5893-b9b3-8e59327aec57"
}