Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis

May 4, 2009 updated by: Luzerner Kantonsspital

Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial

Neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success.

Objective: To evaluate the effect of Procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric 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 with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • children's Hospital of Lucerne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Term and near-term infants with a gestational age of more than 34 weeks
  • Admitted to the Children's Hospital of Lucerne, Switzerland
  • Suspected neonatal early-onset sepsis
  • Antibiotic therapy
  • Parental consent

Exclusion Criteria:

  • Surgery in the first 3 days of life
  • Severe congenital malformations
  • Chromosomal abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procalcitonin group
Antibiotic therapy is discontinued when two consecutive Procalcitonin values are below predefined age-adjusted cut-off values. Antibiotic therapy could be prolonged despite fulfilled Procalcitonin criteria at the discretion of the attending physician.
Other: Procalcitonin-guided decision making
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis
No Intervention: Standard group
Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic Treatment for More Than 72 Hours
Time Frame: 1 month
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
1 month
Absolute Duration of Antibiotic Therapy
Time Frame: 1 month
Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Martin Stocker, MD, Children's Hospital Lucerne, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCTStocker

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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