{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T20:01:08Z","timestamp":1793217668413,"version":"4.5.0"},"reference-count":66,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T00:00:00Z","timestamp":1686182400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Global Antibiotic Research and Development Partnership","id":[{"id":"https:\/\/ror.org\/0284j4180","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"name":"German Federal Ministry of Education and Research","id":[{"id":"https:\/\/ror.org\/04pz7b180","id-type":"ROR","asserted-by":"crossref"}]},{"name":"German Federal Ministry of Health","id":[{"id":"https:\/\/ror.org\/05vp4ka74","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Government of the principality of Monaco"},{"name":"The Indian Council for Medical Research"},{"DOI":"10.13039\/501100003478","name":"Japanese Ministry of Health, Labour and Welfare","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100003478","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Netherlands Ministry of Health, Welfare and Sport","id":[{"id":"https:\/\/ror.org\/041evnj42","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]},{"name":"UK Department of Health and Social Care (UK National Institute of Health Research and the Global Antibiotic Resistance Innovation Fund -","id":[{"id":"https:\/\/ror.org\/03sbpja79","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000265","name":"UK Medical Research Council","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"name":"LEO Model Foundation"},{"name":"Luxembourg Ministry of Development Cooperation and Humanitarian Aid"},{"name":"Luxembourg Ministry of Health"},{"DOI":"10.13039\/100008196","name":"M\u00e9decins Sans Fronti\u00e8res","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008196","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Swiss Federal Office of Public Health","id":[{"id":"https:\/\/ror.org\/01qtc5416","id-type":"ROR","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100020171","name":"Foreign, Commonwealth and Development Office","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100020171","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosmedicine.org"],"crossmark-restriction":false},"short-container-title":["PLoS Med"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods and findings<\/jats:title>\n                    <jats:p>Hospitalized infants &lt;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.<\/jats:p>\n                    <jats:p>\n                      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                      <jats:italic>n<\/jats:italic>\n                      = 814) of infants started WHO first line regimens (Group 1\u2014Access) and 13.8% (\n                      <jats:italic>n<\/jats:italic>\n                      = 432) started WHO second-line cephalosporins (cefotaxime\/ceftriaxone) (Group 2\u2014\u201cLow\u201d Watch). The largest group (34.0%,\n                      <jats:italic>n<\/jats:italic>\n                      = 1,068) started a regimen providing partial extended-spectrum beta-lactamase (ESBL)\/pseudomonal coverage (piperacillin-tazobactam, ceftazidime, or fluoroquinolone-based) (Group 3\u2014\u201cMedium\u201d Watch), 18.0% (\n                      <jats:italic>n<\/jats:italic>\n                      = 566) started a carbapenem (Group 4\u2014\u201cHigh\u201d Watch), and 1.8% (\n                      <jats:italic>n<\/jats:italic>\n                      = 57) a Reserve antibiotic (Group 5, largely colistin-based), and 728\/2,880 (25.3%) of initial regimens in Groups 1 to 4 were escalated, mainly to carbapenems, usually for clinical deterioration (\n                      <jats:italic>n<\/jats:italic>\n                      = 480; 65.9%).\n                    <\/jats:p>\n                    <jats:p>\n                      A total of 564\/3,195 infants (17.7%) were blood culture pathogen positive, of whom 62.9% (\n                      <jats:italic>n<\/jats:italic>\n                      = 355) had a gram-negative organism, predominantly\n                      <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      (\n                      <jats:italic>n<\/jats:italic>\n                      = 132) or\n                      <jats:italic>Acinetobacter<\/jats:italic>\n                      spp. (\n                      <jats:italic>n<\/jats:italic>\n                      = 72). Both were commonly resistant to WHO-recommended regimens and to carbapenems in 43 (32.6%) and 50 (71.4%) of cases, respectively. MRSA accounted for 33 (61.1%) of 54\n                      <jats:italic>Staphylococcus aureus<\/jats:italic>\n                      isolates.\n                    <\/jats:p>\n                    <jats:p>\n                      Overall, 350\/3,204 infants died (11.3%; 95% CI 10.2% to 12.5%), 17.7% if blood cultures were positive for pathogens (95% CI 14.7% to 21.1%,\n                      <jats:italic>n<\/jats:italic>\n                      = 99\/564). A baseline NeoSep Severity Score had a C-index of 0.76 (0.69 to 0.82) in the validation sample, with mortality of 1.6% (3\/189; 95% CI: 0.5% to 4.6%), 11.0% (27\/245; 7.7% to 15.6%), and 27.3% (12\/44; 16.3% to 41.8%) in low (score 0 to 4), medium (5 to 8), and high (9 to 16) risk groups, respectively, with similar performance across subgroups. A related NeoSep Recovery Score had an area under the receiver operating curve for predicting death the next day between 0.8 and 0.9 over the first week. There was significant variation in outcomes between sites and external validation would strengthen score applicability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Antibiotic 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov, (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03721302\" xlink:type=\"simple\">NCT03721302<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pmed.1004179","type":"journal-article","created":{"date-parts":[[2023,6,8]],"date-time":"2023-06-08T13:21:18Z","timestamp":1686230478000},"page":"e1004179","update-policy":"https:\/\/doi.org\/10.1371\/journal.pmed.corrections_policy","source":"Crossref","is-referenced-by-count":181,"title":["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)"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9538-7695","authenticated-orcid":true,"given":"Neal 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