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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial

Conditions
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Sepsis

Intervention / Treatment
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* Other: Procalcitonin-guided decision making


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procalcitonin group<br>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<br>* Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis<br>|
| No Intervention: Standard group<br>Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic Treatment for More Than 72 Hours | Infants treated with antibiotics for more than 72 hours (efficacy of study intervention) | 1 month | 
| 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) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic therapy, early-onset sepsis, interventions study, procalcitonin, term and near-term neonates