1348. Efficacy And Safety Of Procalcitonin-Guided-Decision Making In Neonates Suspected Of Early Onset Sepsis: The Neopins Study - An International, Multicenter Non-inferiority Randomized Controlled Intervention Trial.
Session: Poster Abstract Session: Clinical Trials
Friday, October 28, 2016
Room: Poster Hall
Background: Uncertainty about the presence of neonatal early-onset sepsis (EOS) results in unnecessary and prolonged empiric antibiotic treatment. This study evaluates whether Procalcitonin (PCT)-guided treatment for suspected EOS can reduce the duration of antibiotic treatment with unchanged outcome (re-infection/death in the first month of life with 2% margin for non-inferiority).

Methods: Randomized controlled intervention trial recruiting neonates (gestational age ≥ 34 weeks) suspected of EOS requiring antibiotic therapy. Patients were stratified in 4 risk-categories and randomized for duration of antibiotic treatment based on PCT-guided-decision-making or standard care. Analyses were done as intention-to-treat (ITT) as well as per protocol (PP).

Results: 1710 neonates were randomized and included in the ITT analysis, 1408 in the PP analysis. The duration of antibiotic therapy was significantly shorter in the PCT-group than in the standard group (ITT: 55.1 vs. 65.0 hours, p<0.001; PP: 40.0 vs. 62.0 hours; p<0.001). Length of hospital stay was significantly (p=0.0028) reduced in the PCT group with a small effect size (ITT: -3.5 hours; PP: -5.2 hours). No sepsis related deaths occurred and the rate of possible re-infection was below 1% with a risk difference of 0.1% (exact CI -4.6 to 4.8%). Non-inferiority (margin 2%) could not be statistically proven due to the low occurrence of possible relapse infections.

Conclusion: Initial risk assessment for suspected EOS and PCT-guidance on duration of empirical antibiotic therapy results in a significant reduction of duration of antibiotic therapy and length of hospital stay. The effect size is dependent on protocol adherence. The used approach seems to be safe whereas non-inferiority cannot be claimed statistically.

Wendy Van Herk, MD1, Martin Stocker, MD2, Salhab El Helou, MD3, Matteo Fontana, MD2, Frank a.B.a. Schuerman, MD4, H.K. Van Den Tooren, MD5, Jantien Bolt, MD6, Jan Janota, MD7,8, Laura H. Van Der Meer, MD9, Rob Moonen, MD10, Sintha D. Sie, MD PhD11, Esther De Vries, MD12, Albertine Donker, MD13, Urs Zimmermann, MD14, Luregn G. Schlapbach, MD PhD15,16, Amerik C. De Mol, MD PhD17, Angelique Haringsma, MD18, Roy Madan, MD19, Maren Tomaske, MD20, Rene F. Kornelisse, MD PhD21, Juliette Van Gijsel, MD22, Eline G. Visser, Drs1, Sten P. Willemsen, Drs23, Wim Hop, Ir23 and Annemarie M.C. Van Rossum, MD, PhD1, (1)Pediatric Infectious Diseases, Immunology & Rheumatology, Erasmus MC Univ. Med. Ctr. - Sophia Children's Hosp., Rotterdam, Netherlands, (2)Neonatology, Children's Hosp. Lucerne, Lucerne, Switzerland, (3)Neonatology, McMaster Univ. Children's Hosp., Hamilton Health Services, Hamilton, ON, Canada, (4)Pediatrics, Flevo Ziekenhuis, Almere, Netherlands, (5)Pediatrics, Bronovo Hosp., the Hague, Netherlands, (6)Pediatrics, MC Haaglanden Westeinde, the Hague, Netherlands, (7)Thomayer Hosp., Prague, Czech Republic, (8)Neonatology, Charles Univ. First Med. Faculty, Prague, Czech Republic, (9)Neonatology, Reinier de Graaf Gasthuis, Delft, Netherlands, (10)Neonatology, Atrium Med. Ctr. Heerlen, Heerlen, Netherlands, (11)Neonatology, VU Univ. Med Ctr., Amsterdam, Netherlands, (12)Pediatrics, Jeroen Bosch Ziekenhuis, 's Hertogenbosch, Netherlands, (13)Pediatrics, Maxima Med. Ctr., Veldhoven, Netherlands, (14)Pediatrics, Kantonsspital Winterthur, Wintherthur, Switzerland, (15)Pediatrics, Inselspital Univ. of Bern, Bern, Switzerland, (16)Mater Res. Inst. Univ. of Queensland, South Brisbane Qld 4101, Australia, (17)Neonatology, Albert Schweitzer Hosp., Dordrecht, Netherlands, (18)Neonatology, Sint Franciscus Gasthuis, Rotterdam, Netherlands, (19)Neonatology, St. Joseph Healthcare, Hamilton Health Services, Hamilton, ON, Canada, (20)Pediatrics, Univ. Children's Hosp., Zurich, Switzerland, (21)Neonatology, Erasmus MC University Medical Center - Sophia Children's Hospital, Rotterdam, Netherlands, (22)Julius Training General Practitioner, Univ. Med. Ctr. Utrecht, Utrecht, Netherlands, (23)Biostatistics, Erasmus Univ. Med. Ctr., Rotterdam, Netherlands


W. Van Herk, None

M. Stocker, None

S. El Helou, None

M. Fontana, None

F. A. B. A. Schuerman, None

H. K. Van Den Tooren, None

J. Bolt, None

J. Janota, None

L. H. Van Der Meer, None

R. Moonen, None

S. D. Sie, None

E. De Vries, None

A. Donker, None

U. Zimmermann, None

L. G. Schlapbach, None

A. C. De Mol, None

A. Haringsma, None

R. Madan, None

M. Tomaske, None

R. F. Kornelisse, None

J. Van Gijsel, None

E. G. Visser, None

S. P. Willemsen, None

W. Hop, None

A. M. C. Van Rossum, None

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