{
  "abstract": "Objective Definitive guidance regarding the duration of antibiotics for neonatal sepsis is lacking. We hypothesised that a 7-day antibiotic course is non-inferior to a 14-day course for treating culture-proven sepsis.Design Randomised, controlled, non-inferiority trial with masked outcome assessment in eight centres in a low and middle-income country.Patients Neonates with a birth weight (BW) ≥1000 g and blood culture-proven sepsis were randomised on day 7 of sensitive antibiotic therapy provided sepsis had clinically remitted. Exclusions: Staphylococcus aureus or fungal sepsis, and infections requiring prolonged antibiotics. We planned to enrol 350 per group, assuming 10% rate of primary outcome, +7% non-inferiority margin, one-sided 5% alpha, 90% power, 10% loss to follow-up.Intervention 7 days (no further treatment); comparison: 14 days (7 days postrandomisation).Outcomes Primary: relapse (definite or probable) within day 21 postantibiotic completion. Secondary outcomes: composite of mortality or definite/probable/secondary sepsis and duration of hospitalisation. One interim analysis (per protocol (PP)) was planned.Results 126 and 135 subjects were recruited in 7-day and 14-day groups, respectively, with mean (SD) birth weight (BW) 2250.9 (741.1) and 2187.8 (718.8) g. The trial was terminated early, based on interim PP analysis. 2/125 and 6/130 subjects had the primary outcome in 7-day and 14-day groups, respectively (risk difference (RD)=−3.0% (99.5% CI −9.2%, +3.1%), below non-inferiority margin). The composite secondary outcome also favoured the 7-day regimen (RD: −3.7% (99.5% CI −12.4% to +5.1%)). Duration of hospitalisation was shorter in 7-day group (median difference: −4 days (95% CI −5 to –3)).Conclusions A 7-day course of antibiotics may be non-inferior to a 14-day course for uncomplicated bacterial neonatal sepsis.Trial registration number NCT03280147.",
  "authors": [
    {
      "affiliations": [
        "Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India"
      ],
      "name": "Sourabh Dutta"
    },
    {
      "affiliations": [
        "Department of Neonatology, Lady Hardinge Medical College, New Delhi, India"
      ],
      "name": "Sushma Nangia"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Chacha Nehru Bal Chikitsalaya, Delhi, India"
      ],
      "name": "Mamta Jajoo"
    },
    {
      "affiliations": [
        "Department of Neonatology, Madras Medical College, Chennai, India"
      ],
      "name": "MangalaBharathi Sundaram"
    },
    {
      "affiliations": [
        "Department of Pediatrics, King George Medical University, Lucknow, India"
      ],
      "name": "Mala Kumar"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Indira Gandhi Institute of Child Health, Bengaluru, India"
      ],
      "name": "Niranjan Shivanna"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Pt. Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences, Rohtak, India"
      ],
      "name": "Geeta Gathwala"
    },
    {
      "affiliations": [
        "Department of Neonatology, St John’s Medical College Hospital, Bengaluru, India"
      ],
      "name": "Saudamini Nesargi"
    },
    {
      "affiliations": [
        "Department of Neonatology, Government Medical College and Hospital, Chandigarh, India"
      ],
      "name": "Suksham Jain"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India"
      ],
      "name": "Praveen Kumar"
    },
    {
      "affiliations": [
        "Department of Neonatology, Lady Hardinge Medical College, New Delhi, India"
      ],
      "name": "Arvind Saili"
    },
    {
      "affiliations": [
        "Department of Neonatology, Madras Medical College, Chennai, India"
      ],
      "name": "Arun Karthik"
    },
    {
      "affiliations": [
        "Department of Pediatrics, King George Medical University, Lucknow, India"
      ],
      "name": "Shalini Tripathi"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Indira Gandhi Institute of Child Health, Bengaluru, India"
      ],
      "name": "Prathik Bandiya"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Pt. Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences, Rohtak, India"
      ],
      "name": "Poonam Dalal"
    },
    {
      "affiliations": [
        "Department of Medical Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India"
      ],
      "name": "Pallab Ray"
    },
    {
      "affiliations": [
        "Department of Neonatology, Lady Hardinge Medical College, New Delhi, India"
      ],
      "name": "Valinderjeet Singh Randhawa"
    },
    {
      "affiliations": [
        "Department of Microbiology, Chacha Nehru Bal Chikitsalaya, Delhi, India"
      ],
      "name": "Karnika Saigal"
    },
    {
      "affiliations": [
        "Department of Microbiology, Madras Medical College, Chennai, India"
      ],
      "name": "Devasena Radhakrishnan"
    },
    {
      "affiliations": [
        "Department of Microbiology, King George Medical University, Lucknow, India"
      ],
      "name": "Vimla Venkatesh"
    },
    {
      "affiliations": [
        "Department of Microbiology, Indira Gandhi Institute of Child Health, Bengaluru, India"
      ],
      "name": "Bhavana Jagannatha"
    },
    {
      "affiliations": [
        "Department of Microbiology, Pt. Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences, Rohtak, India"
      ],
      "name": "Madhu Sharma"
    },
    {
      "affiliations": [
        "Department of Microbiology, St John’s Medical College Hospital, Bengaluru, India"
      ],
      "name": "Savitha Nagaraj"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India"
      ],
      "name": "Meenakshi Malik"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India"
      ],
      "name": "Sarita Dogra"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India"
      ],
      "name": "Suruchi Mittal"
    },
    {
      "affiliations": [
        "Department of Neonatology, Lady Hardinge Medical College, New Delhi, India"
      ],
      "name": "Anumeet Saini"
    },
    {
      "affiliations": [
        "Department of Neonatology, Lady Hardinge Medical College, New Delhi, India"
      ],
      "name": "Nisha Makkar"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Chacha Nehru Bal Chikitsalaya, Delhi, India"
      ],
      "name": "Maitreyi Dhir"
    },
    {
      "affiliations": [
        "Department of Neonatology, Madras Medical College, Chennai, India"
      ],
      "name": "Asmita Chandramohan"
    },
    {
      "affiliations": [
        "Department of Pediatrics, King George Medical University, Lucknow, India"
      ],
      "name": "R A Pragati"
    },
    {
      "affiliations": [
        "Department of Pediatrics, King George Medical University, Lucknow, India"
      ],
      "name": "Tanaya Srivastava"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Indira Gandhi Institute of Child Health, Bengaluru, India"
      ],
      "name": "Lakshmi Mukundan"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Indira Gandhi Institute of Child Health, Bengaluru, India"
      ],
      "name": "Naveen Benakappa"
    },
    {
      "affiliations": [
        "Indian Council of Medical Research, New Delhi, India"
      ],
      "name": "Amlin Shukla"
    },
    {
      "affiliations": [
        "Indian Council of Medical Research, New Delhi, India"
      ],
      "name": "Reeta Rasaily"
    }
  ],
  "title": "Seven-day versus 14-day antibiotic course for culture-proven neonatal sepsis: a multicentre randomised non-inferiority trial in a low and middle-income country",
  "uid": "f56282bf-84e3-5c67-a9b5-41c4dd57b8b9"
}