Effect of procalcitonin-guided decision making on duration of antibiotic therapy in suspected early-onset neonatal sepsis: multicenter prospective randomized intervention study

Completed

• Conditions: infection in newborns; 10004018

• Registration Number: NL-OMON39201
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-02-14
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1071

Inclusion Criteria

Gestational age 34 weeks or more; 3 or less days old; suspected infection requiring empiric antibiotic therapy; parental informed consent

Exclusion Criteria

Surgery before or during the study; severe malformations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* The proportion of infants with a recurrence of infection requiring additional<br /><br>courses of antibiotic therapy in the first month of life, within 72 hours<br /><br>after ending antibiotic therapy (safety of study intervention)<br /><br><br /><br>* The absolute reduction of the duration of antibiotic therapy<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Mortality<br /><br>* Duration of hospitalization</p><br>