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

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Procalcitonin-guided decision making
Sponsored by
Luzerner Kantonsspital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring antibiotic therapy, early-onset sepsis, interventions study, procalcitonin, term and near-term neonates

Eligibility Criteria

undefined - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • children's Hospital of Lucerne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Procalcitonin group

Standard group

Arm Description

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.

Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2009
Last Updated
May 4, 2009
Sponsor
Luzerner Kantonsspital
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1. Study Identification

Unique Protocol Identification Number
NCT00926497
Brief Title
Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Official Title
Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Luzerner Kantonsspital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
antibiotic therapy, early-onset sepsis, interventions study, procalcitonin, term and near-term neonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procalcitonin group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Intervention Type
Other
Intervention Name(s)
Procalcitonin-guided decision making
Intervention Description
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis
Primary Outcome Measure Information:
Title
Antibiotic Treatment for More Than 72 Hours
Description
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Time Frame
1 month
Title
Absolute Duration of Antibiotic Therapy
Description
Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)
Time Frame
1 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Stocker, MD
Organizational Affiliation
Children's Hospital Lucerne, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
children's Hospital of Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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