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1. 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).

Author

Neal J Russell, Wolfgang Stöhr, Nishad Plakkal, Aislinn Cook, James A Berkley, Bethou Adhisivam, Ramesh Agarwal, Nawshad Uddin Ahmed, Manica Balasegaram, Daynia Ballot, Adrie Bekker, Eitan Naaman Berezin, Davide Bilardi, Suppawat Boonkasidecha, Cristina G Carvalheiro, Neema Chami, Suman Chaurasia, Sara Chiurchiu, Viviane Rinaldi Favarin Colas, Simon Cousens, Tim R Cressey, Ana Carolina Dantas de Assis, Tran Minh Dien, Yijun Ding, Nguyen Trong Dung, Han Dong, Angela Dramowski, Madhusudhan Ds, Ajay Dudeja, Jinxing Feng, Youri 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 M Mussi-Pinhata, Ruchi Nanavati, Firdose Nakwa, Sushma Nangia, Jolly Nankunda, Alessandra Nardone, Borna Nyaoke, Christina W Obiero, Maxensia Owor, Wang Ping, 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 A Bielicki, A Sarah Walker, Paul T Heath, and Mike Sharland

Subjects
Medicine
Abstract

BackgroundThere 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 findingsHospitalized infants ConclusionAntibiotic regimens used in neonatal sepsis commonly diverge from WHO guidelines, and trials of novel empiric regimens are urgently needed in the context of increasing antimicrobial resistance (AMR). The baseline NeoSep Severity Score identifies high mortality risk criteria for trial entry, while the NeoSep Recovery Score can help guide decisions on regimen change. NeoOBS data informed the NeoSep1 antibiotic trial (ISRCTN48721236), which aims to identify novel first- and second-line empiric antibiotic regimens for neonatal sepsis.Trial registrationClinicalTrials.gov, (NCT03721302).

Published
2023
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2. The NeoSep Severity and Recovery scores to predict mortality in hospitalized neonates and young infants with sepsis derived from the global NeoOBS observational cohort study

Author

Neal Russell, Wolfgang Stöhr, Aislinn Cook, James A Berkley, Bethou Adhisivam, Ramesh Agarwal, Nawshad Uddin Ahmed, Manica Balasegaram, Neema Chami, Adrie Bekker, Davide Bilardi, Cristina G. Carvalheiro, Suman Chaurasia, Viviane Rinaldi Favarin Colas, Simon Cousens, Ana Carolina Dantas de Assis, Han Dong, Angela Dramowski, Nguyen Trong Dung, Jinxing Feng, Youri Glupczynski, Srishti Goel, Herman Goossens, Doan Thi Huong Hao, Mahmudul Hasan, Tatiana Munera Huertas, Nathalie Khavessian, Angeliki Kontou, Tomislav Kostyanev, Premsak Laoyookhon, Sorasak Lochindarat, Maia De Luca, Surbhi Malhotra-Kumar, Nivedita Mondal, Nitu Mundhra, Philippa Musoke, Marisa M. Mussi-Pinhata, Ruchi Nanavati, Firdose L. Nakwa, Sushma Nangia, Alessandra Nardone, Borna Nyaoke, Christina W Obiero, Wang Ping, Kanchana Preedisripipat, Shamim Qazi, Lifeng Qi, Amy Riddell, Lorenza Romani, Praewpan Roysuwan, Robin Saggers, Samir Saha, Kosmas Sarafidis, Valerie Tusibira, Sithembiso Velaphi, Tuba Vilken, Xiaojiao Wang, Yajuan Wang, Yonghong Yang, Sally Ellis, Julia Bielicki, A Sarah Walker, Paul T. Heath, and Mike Sharland

Abstract

BackgroundSepsis severity scores are used in clinical practice and trials to define risk groups. There are limited data to derive hospital-based sepsis severity scores for neonates and young infants in high-burden low- and middle-income country (LMIC) settings where trials are urgently required. We aimed to create linked sepsis severity and recovery scores applicable to hospitalized neonates and young infants in LMIC which could be used to inform antibiotic trials.Methods & FindingsA prospective observational cohort study was conducted across 19 hospitals in 11 countries in sub-Saharan Africa, Asia, Latin America and Europe. Infants aged 3204 infants were enrolled between 2018-2020. Median age was 5 days (IQR 2-15), 90.4% (n=2,895) were A related NeoSep Recovery Score based on evolving post-baseline clinical signs and supportive care discriminated well between infants who died or survived the following day or subsequent few days. The area under the ROC curve for score on day 2 and death in the following 5 days was 0.82 (95%CI 0.78-0.85) and 0.85 (95%CI 0.78-0.93) in the derivation and validation data, respectively.ConclusionThe baseline NeoSep Severity Score predicted 28-day mortality and could identify infants with high risk of mortality for inclusion in hospital-based sepsis trials. The NeoSep Recovery Score predicts day-by-day inpatient mortality and could, with further validation, help to identify poor response to antibiotics.Author SummaryWhy was this study done?➣Evidence to guide hospital-based antibiotic treatment of sepsis in neonates and young infants is scarce, and clinical trials are particularly urgent in low- and middle-income (LMIC) settings where antimicrobial resistance threatens to undermine existing guidelines➣There is limited data to inform the design of antibiotic trials in LMIC settings, particularly to define risk stratification and inclusion and escalation criteria in hospitalised neonates and young infantsWhat did the researchers do and find?➣To our knowledge this is the first global, prospective, hospital-based observational study of clinically diagnosed neonatal sepsis across 4 continents including LMIC settings, with extensive daily data collection on clinical status, antibiotic use and outcomes.➣There was a high mortality among infants with sepsis in LMIC hospital settings. 4 non-modifiable and 6 modifiable factors predicted mortality and were included in a NeoSep Severity score which defines patterns of mortality risk at baseline➣A NeoSep Recovery Score including the same modifiable factors (with the addition of cyanosis) predicted mortality on the following day during the course of treatment.What do these findings mean?➣The NeoSep Severity Score and NeoSep Recovery score are now informing inclusion and escalation criteria in the NeoSep1 antibiotic trial (ISRCTN48721236) which aims to identify novel first- and second-line empiric antibiotic regimens for neonatal sepsis➣The NeoSep Severity Score could be used to predict mortality at baseline in future studies of targeting resources in routine care. With further validation, the NeoSep Recovery Score could potentially be used to identify poor response to empiric antibiotic treatment

Published
2022

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