Fax +41 61 306 12 34 E-Mail karger@karger.ch www.karger.com Original Paper Neonatology 2010;97:165–174 DOI: 10.1159/000241296 Use of Procalcitonin-Guided Decision-Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial Martin Stocker a Matteo Fontana a Salhab el Helou a Karl Wegscheider b Thomas M. Berger a a Neonatal and Pediatric Intensive Care Unit, Children’s Hospital of Lucerne, Switzerland, and b Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany tors for early-onset sepsis, likelihood of infection as assessed by the attending physician and early conventional labora- tory findings. There was a significant difference in the pro- portion of newborns treated with antibiotics 672 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: Se- rial PCT determinations allow to shorten the duration of an- tibiotic therapy in term and near-term infants with suspect- ed early-onset sepsis. Before this PCT-guided strategy can be recommended, its safety has to be confirmed in a larger cohort of neonates. Copyright © 2009 S. Karger AG, Basel Introduction In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available laboratory tests have poor positive and negative predictive values. Delay in antibiotic treatment of infect- ed neonates carries a substantial risk, both in terms of mortality and morbidity. Therefore, newborns with sus- pected sepsis (based on clinical signs and/or perinatal/ Key Words Antibiotic therapy  Early-onset sepsis  Intervention study  Procalcitonin  Term and near-term neonates Abstract Background: Diagnosis of neonatal early-onset sepsis is dif- ficult because clinical signs and laboratory tests are non- specific. Early antibiotic therapy is crucial for treatment suc- cess. 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 in- tensive care unit in the Children’s Hospital of Lucerne, Swit- zerland, between June 1, 2005 and December 31, 2006. All term and near-term infants (gestational age 634 weeks) with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional labora- tory parameters (standard group) or to PCT-guided treat- ment (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 val- ues. 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 fac- Received: July 24, 2008 Accepted after revision: February 9, 2009 Published online: September 24, 2009 formerly Biology of the Neonate Martin Stocker, MD Pediatric Intensive Care Unit Royal Brompton Hospital, Sydney Street London SW3 6NP (UK) Tel. +41 79 373 67 19, E-Mail stockermartin@mail.com © 2009 S. Karger AG, Basel 1661–7800/10/0972–0165$26.00/0 Accessible online at: www.karger.com/neo