title: Clinical outcome of neonates with nosocomial suspected sepsis treated with cefazolin or vancomycin: a non-inferiority, randomized, controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  Cefazolin was not inferior to vancomycin in achieving an adequate clinical outcome in newborn infants with confirmed or highly probable nosocomial sepsis.
authors: División de Neonatología, Departamento de Pediatría, Hospital Italiano de Buenos Aires, Buenos Aires.
authors: José M
authors: JM
authors: Ceriani Cernadas
authors: División de Neonatología, Departamento de Pediatría, Hospital Italiano de Buenos Aires, Buenos Aires.
authors: Silvia
authors: S
authors: Fernández Jonusas
authors: División de Neonatología, Departamento de Pediatría, Hospital Italiano de Buenos Aires, Buenos Aires.
authors: Maritza
authors: M
authors: Márquez
authors: División de Estadística, Illurnina, Inc, CA, EE. UU.
authors: Armando
authors: A
authors: Garsd
authors: División de Neonatología, Departamento de Pediatría, Hospital Italiano de Buenos Aires, Buenos Aires.
authors: Gonzalo
authors: G
authors: Mariani
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002437:Cefazolin / Q000627:therapeutic use*; D003428:Cross Infection / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D011446:Prospective Studies; D018805:Sepsis / Q000188:drug therapy*; D013203:Staphylococcal Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin; D002437:Cefazolin