Neonatal Procalcitonin Intervention Study

Summary

In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.

Conditions

• Sepsis

Interventions

OTHER

Procalcitonin-guided decision making

In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.

Sponsors & Collaborators

• Kantonsspital Winterthur KSW

  collaborator OTHER

• Triemli Hospital

  collaborator OTHER

• Kantonsspital Graubuenden

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Jeroen Bosch Ziekenhuis, s'-Hertogenbosch

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  collaborator OTHER

• Reinier de Graaf Groep

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Thomayer University Hospital

  collaborator OTHER

• Flevo Ziekenhuis, Almere

  collaborator UNKNOWN

• Atrium Medisch Centrum, Heerlen

  collaborator UNKNOWN

• Ijssalland Ziekenhuis, Capelle aan den Ijssel

  collaborator UNKNOWN

• Sint Franciscus Gasthuis

  collaborator OTHER

• Vlietland Ziekenhuis

  collaborator OTHER

• McMaster University

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  collaborator OTHER

• Luzerner Kantonsspital

  lead OTHER

Principal Investigators

• Martin Stocker, MD · Kantonsspital Luzern, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

3 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2015-05-31

Completion

2016-08-31

Countries

• Switzerland

Study Locations