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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00926497
First Posted: June 23, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Luzerner Kantonsspital
  Purpose

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.


Condition Intervention
Sepsis Other: Procalcitonin-guided decision making

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Antibiotic Treatment for More Than 72 Hours [ Time Frame: 1 month ]
  • Absolute Duration of Antibiotic Therapy [ Time Frame: 1 month ]

Enrollment: 121
Study Start Date: June 2005
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926497


Locations
Switzerland
children's Hospital of Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
Principal Investigator: Martin Stocker, MD Children's Hospital Lucerne, Switzerland
  More Information

Responsible Party: Martin Stocker, MD, Children's Hospital Lucerne
ClinicalTrials.gov Identifier: NCT00926497     History of Changes
Other Study ID Numbers: PCTStocker
First Submitted: January 16, 2009
First Posted: June 23, 2009
Results First Submitted: January 16, 2009
Results First Posted: June 23, 2009
Last Update Posted: July 29, 2009
Last Verified: May 2009

Keywords provided by Luzerner Kantonsspital:
antibiotic therapy
early-onset sepsis
interventions study
procalcitonin
term and near-term neonates

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcitonin
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs


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