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

This study has been completed.
Sponsor:
Information provided by:
Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00926497
First received: January 16, 2009
Last updated: May 4, 2009
Last verified: May 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Absolute Duration of Antibiotic Therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

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
Other Name: Procalcitonin-guided decision making
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

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Martin Stocker, MD, Children's Hospital Lucerne
ClinicalTrials.gov Identifier: NCT00926497     History of Changes
Other Study ID Numbers: PCTStocker
Study First Received: January 16, 2009
Results First Received: January 16, 2009
Last Updated: May 4, 2009
Health Authority: Switzerland: Ethikkommission

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
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014