BACKGROUND: Nosocomial infections are a major problem in Neonatal Intensive Care Units. Coagulase negative Staphylococcus (CONS) is the most common causative agent. We evaluated the efficacy of cefazolin versus vancomycin as initial therapy for neonates with presumptive clinical signs of nosocomial sepsis probably caused by CONS. METHODS: Hospitalized newborns infants with clinical signs of very probable bacterial sepsis were included. Two groups were randomly assigned according the initial antibiotic therapy: cefazolin group (CG) or vancomycin group (VG). The primary analysis was performed on an intention-to-treat basis. The main outcome measure was the clinical outcome of infants in both groups at the end of antibiotic treatment. RESULTS: We analyzed 109 newborns, 52 in CG and 57 in VG. Baseline characteristics were similar among groups. The percentage of neonates with adequate outcome was 92% in the CG and 86% in the VG: difference: 6% (95% CI: -7% to 19%, p-value non-inferiority, p = 0.007). Seven infants died in the CG (13.5%) and and 11 (19.2%) in the VG; no significant difference (p=0.45). CONCLUSION: Cefazolin was not inferior to vancomycin in achieving an adequate clinical outcome in newborn infants with confirmed or highly probable nosocomial sepsis.
BACKGROUND: Nosocomial infections are a major problem in Neonatal Intensive Care Units. Coagulase negative Staphylococcus (CONS) is the most common causative agent. We evaluated the efficacy of cefazolin versus vancomycin as initial therapy for neonates with presumptive clinical signs of nosocomial sepsis probably caused by CONS. METHODS: Hospitalized newborns infants with clinical signs of very probable bacterial sepsis were included. Two groups were randomly assigned according the initial antibiotic therapy: cefazolin group (CG) or vancomycin group (VG). The primary analysis was performed on an intention-to-treat basis. The main outcome measure was the clinical outcome of infants in both groups at the end of antibiotic treatment. RESULTS: We analyzed 109 newborns, 52 in CG and 57 in VG. Baseline characteristics were similar among groups. The percentage of neonates with adequate outcome was 92% in the CG and 86% in the VG: difference: 6% (95% CI: -7% to 19%, p-value non-inferiority, p = 0.007). Seven infants died in the CG (13.5%) and and 11 (19.2%) in the VG; no significant difference (p=0.45). CONCLUSION: Cefazolin was not inferior to vancomycin in achieving an adequate clinical outcome in newborn infants with confirmed or highly probable nosocomial sepsis.
Authors: Cían J Henry; Gergana Semova; Ellen Barnes; Isabel Cotter; Tara Devers; Aisyah Rafaee; Andreea Slavescu; Niamh O Cathain; Danielle McCollum; Edna Roche; David Mockler; John Allen; Judith Meehan; Claus Klingenberg; Jos M Latour; Agnes van den Hoogen; Tobias Strunk; Eric Giannoni; Luregn J Schlapbach; Marina Degtyareva; Frans B Plötz; Willem P de Boode; Lars Naver; James L Wynn; Helmut Küster; Jan Janota; Fleur M Keij; Irwin K M Reiss; Joseph M Bliss; Richard Polin; Joyce M Koenig; Mark A Turner; Christopher Gale; Eleanor J Molloy Journal: Pediatr Res Date: 2022-01-07 Impact factor: 3.953