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.
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Dutta Sourabh, Nangia Sushma, Jajoo Mamta, Sundaram MangalaBharathi, Kumar Mala, Shivanna Niranjan, Gathwala Geeta, Nesargi Saudamini, Jain Suksham, Kumar Praveen, Saili Arvind, Karthik Arun, Tripathi Shalini, Bandiya Prathik, Dalal Poonam, Ray Pallab, Randhawa Valinderjeet Singh, Saigal Karnika, Radhakrishnan Devasena, Venkatesh Vimla, Jagannatha Bhavana, Sharma Madhu, Nagaraj Savitha, Malik Meenakshi, Dogra Sarita, Mittal Suruchi, Saini Anumeet, Makkar Nisha, Dhir Maitreyi, Chandramohan Asmita, Pragati R A, Srivastava Tanaya, Mukundan Lakshmi, Benakappa Naveen, Shukla Amlin, Rasaily Reeta
Аннотация
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.