title: Monitoring the treatment of sepsis with vancomycin in term newborn infants.
abstract: A prospective study was conducted to determine if standardized vancomycin doses could produce adequate serum concentrations in 25 term newborn infants with sepsis.
  
  
  OBJECTIVE
  The therapeutic response of neonatal sepsis by Staphylococcus sp. treated with vancomycin was evaluated through serum concentrations of vancomycin, serum bactericidal titers (SBT), and minimum inhibitory concentration (MIC).
  
  
  METHODS
  Vancomycin serum concentrations were determined by the fluorescence polarization immunoassay technique, SBT by the macro-broth dilution method, and MIC by diffusion test in agar.
  
  
  RESULTS
  Thirteen newborn infants (59.1%) had adequate peak vancomycin serum concentrations (20 - 40 mg/mL) and one had peak concentration with potential ototoxicity risk (>40 microg/mL). Only 48% had adequate trough concentrations (5 - 10 mg/mL), and seven (28%) had a potential nephrotoxicity risk (>10 microg/mL). There was no significant agreement regarding normality for peak and trough vancomycin method (McNemar test : p = 0.7905). Peak serum vancomycin concentrations were compared with the clinical evaluation (good or bad clinical evolution) of the infants, with no significant difference found (U=51.5; p=0.1947). There was also no significant difference between the patients' trough concentrations and good or bad clinical evolution (U = 77.0; p=0.1710). All Staphylococcus isolates were sensitive to vancomycin according to the MIC. Half of the patients with adequate trough SBT (1/8), also had adequate trough vancomycin concentrations and satisfactory clinical evolution.
  
  
  CONCLUSIONS
  Recommended vancomycin schedules for term newborn infants with neonatal sepsis should be based on the weight and postconceptual age only to start antimicrobial therapy. There is no ideal pattern of vancomycin dosing; vancomycin dosages must be individualized. SBT interpretation should be made in conjunction with the patient's clinical presentation and vancomycin serum concentrations. Those laboratory and clinical data favor elucidation of the probable cause of patient's bad evolution, which would facilitate drug adjustment and reduce the risk of toxicity or failing to achieve therapeutic doses.
authors.affiliation: Department of Pediatrics, Hospital das Clínicas, Faculty of Medicine, University of São Paulo.
authors.forename: J K
authors.initials: JK
authors.lastname: Machado
authors.forename: R
authors.initials: R
authors.lastname: Feferbaum
authors.forename: E M
authors.initials: EM
authors.lastname: Diniz
authors.forename: T S
authors.initials: TS
authors.lastname: Okay
authors.forename: M E
authors.initials: ME
authors.lastname: Ceccon
authors.forename: F A
authors.initials: FA
authors.lastname: Costa Vaz
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D006801:Humans; D007231:Infant, Newborn; D008826:Microbial Sensitivity Tests; D011446:Prospective Studies; D018805:Sepsis / Q000188:drug therapy*; D015610:Serum Bactericidal Test; D013203:Staphylococcal Infections / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D014640:Vancomycin / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin