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

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: Procalcitonin-guided decision making

• Registration Number: NCT00926497
• Lead Sponsor: Luzerner Kantonsspital

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.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-12
• Study Completion: 2007-01
• Study First Submitted: 2009-01-16
• Results First Submitted: 2009-01-16
• Status Verified: 2009-05
• Study First Submitted QC: 2009-05-04
• Results First Submitted QC: 2009-05-04
• Last Update Submitted: 2009-05-04
• Study First Posted: 2009-06-23
• Results First Posted: 2009-06-23
• Last Update Posted: 2009-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin group	Procalcitonin-guided decision making	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

children's Hospital of Lucerne; 🇨🇭 Lucerne, Switzerland