Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS)

作者：Neal Russell, Wolfgang Stöhr, Nishad Plakkal, Aislinn Cook, James A. Berkley, B. Adhisivam, Ramesh Agarwal, ASM Nawshad Uddin Ahmed, Manica Balasegaram, Daynia Ballot, Adrie Bekker, Eitan Naaman Berezin, Davide Bilardi, Suppawat Boonkasidecha, Cristina Gardonyi Carvalheiro, Neema Chami, Suman Chaurasia, Sara Chiurchiù, Viviane Rinaldi Favarin Colas, Simon Cousens, Tim R. Cressey, Ana Carolina Dantas de Assis, Tran Minh Dien, Yijun Ding, Nguyen Trong Dung, Dong Han, Angela Dramowski, Madhusudhan DS, Ajay Dudeja, Jinxing Feng, Y. Glupczynski, Srishti Goel, Herman Goossens, Doan Thi Huong Hao, Mahmudul Islam Khan, Tatiana Munera Huertas, Mohammad Shahidul Islam, Daniel Jarovsky, Nathalie Khavessian, Meera Khorana, Angeliki Kontou, Tomislav Kostyanev, Premsak Laoyookhon, Sorasak Lochindarat, Mattias Larsson, Maia De Luca, Surbhi Malhotra‐Kumar, Nivedita Mondal, Nitu Mundhra, Philippa Musoke, Marisa Márcia Mussi‐Pinhata, Ruchi Nanavati, Firdose Nakwa, Sushma Nangia, Jolly Nankunda, Alessandra Nardone, Borna Nyaoke, Christina W. Obiero, Maxensia Owor, Ping Wang, Kanchana Preedisripipat, Shamim Qazi, Lifeng Qi, Tanusha Ramdin, Amy Riddell, Lorenza Romani, Praewpan Roysuwan, Robin Saggers, Emmanuel Roilides, Samir K. Saha, Kosmas Sarafidis, Valerie Tusubira, Reenu Thomas, Sithembiso Velaphi, Tuba Vilken, Xiaojiao Wang, Yajuan Wang, Yonghong Yang, Liu Zunjie, Sally Ellis, Julia Bielicki, A. Sarah Walker, Paul T. Heath, Mike Sharland · 发表于：PLoS Medicine · 年份：2023 · DOI：10.1371/journal.pmed.1004179 · 被引用次数：180 · 研究领域：Neonatal and Maternal Infections、Sepsis Diagnosis and Treatment、Preterm Birth and Chorioamnionitis

BACKGROUND: There is limited data on antibiotic treatment in hospitalized neonates in low- and middle-income countries (LMICs). We aimed to describe patterns of antibiotic use, pathogens, and clinical outcomes, and to develop a severity score predicting mortality in neonatal sepsis to inform future clinical trial design. METHODS AND FINDINGS: Hospitalized infants <60 days with clinical sepsis were enrolled during 2018 to 2020 by 19 sites in 11 countries (mainly Asia and Africa). Prospective daily observational data was collected on clinical signs, supportive care, antibiotic treatment, microbiology, and 28-day mortality. Two prediction models were developed for (1) 28-day mortality from baseline variables (baseline NeoSep Severity Score); and (2) daily risk of death on IV antibiotics from daily updated assessments (NeoSep Recovery Score). Multivariable Cox regression models included a randomly selected 85% of infants, with 15% for validation. A total of 3,204 infants were enrolled, with median birth weight of 2,500 g (IQR 1,400 to 3,000) and postnatal age of 5 days (IQR 1 to 15). 206 different empiric antibiotic combinations were started in 3,141 infants, which were structured into 5 groups based on the World Health Organization (WHO) AWaRe classification. Approximately 25.9% (n = 814) of infants started WHO first line regimens (Group 1-Access) and 13.8% (n = 432) started WHO second-line cephalosporins (cefotaxime/ceftriaxone) (Group 2-"Low" Watch). The largest group (34.0%, ...