Use of procalcitonin-guided decision-making to shorten antibiotic therapy in suspected neonatal early-onset sepsis: prospective randomized intervention trial

Neonatology. 2010;97(2):165-74. doi: 10.1159/000241296. Epub 2009 Sep 24.

Abstract

Background: Diagnosis of neonatal early-onset sepsis is difficult because clinical signs and laboratory tests are non-specific. Early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of procalcitonin (PCT)-guided decision-making on duration of antibiotic therapy in suspected neonatal early-onset sepsis.

Methods: This single-center, prospective, randomized intervention study was conducted in a tertiary neonatal and pediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland, between June 1, 2005 and December 31, 2006. All term and near-term infants (gestational age >or=34 weeks) with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to PCT-guided treatment (PCT group). Minimum duration of antibiotic therapy was 48-72 h in the standard group, whereas in the PCT group antibiotic therapy was discontinued when two consecutive PCT values were below predefined age-adjusted cut-off values.

Results: 121 newborns were randomly assigned either to the standard group (n = 61) or the PCT group (n = 60). The two groups were similar for baseline demographics, risk factors for early-onset sepsis, likelihood of infection as assessed by the attending physician and early conventional laboratory findings. There was a significant difference in the proportion of newborns treated with antibiotics >or=72 h between the standard group (82%) and the PCT group (55%) (absolute risk reduction 27%; odds ratio 0.27 (95% CI 0.12-0.62), p = 0.002). On average, PCT-guided decision-making resulted in a shortening of 22.4 h of antibiotic therapy. Clinical outcome was similar and favorable in both groups but sample size was insufficient to exclude rare adverse events.

Conclusion: Serial PCT determinations allow to shorten the duration of antibiotic therapy in term and near-term infants with suspected early-onset sepsis. Before this PCT-guided strategy can be recommended, its safety has to be confirmed in a larger cohort of neonates.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anti-Bacterial Agents / therapeutic use*
  • Biomarkers / blood*
  • C-Reactive Protein / metabolism
  • Calcitonin / blood*
  • Calcitonin Gene-Related Peptide
  • Decision Making
  • Drug Monitoring / methods*
  • Early Diagnosis
  • Female
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Male
  • Prospective Studies
  • Protein Precursors / blood*
  • Sepsis / blood*
  • Sepsis / diagnosis
  • Sepsis / drug therapy*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Biomarkers
  • CALCA protein, human
  • Protein Precursors
  • Calcitonin
  • C-Reactive Protein
  • Calcitonin Gene-Related Peptide