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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis
children's Hospital of Lucerne
Lucerne, Switzerland
Antibiotic Treatment for More Than 72 Hours
Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)
Time frame: 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)
Time frame: 1 month
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