Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- Luzerner Kantonsspital
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Antibiotic Treatment for More Than 72 Hours
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Antibiotic Treatment for More Than 72 Hours
Time Frame: 1 month
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
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)