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

Withdrawn

• Conditions: infection in newborns; 10004018

• Registration Number: NL-OMON33535
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 200

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 during the first week of life
Severe Malformations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the proportion of infants treated with antibiotics for > 48<br /><br>- 72 hours (efficacy of study intervention).<br /><br><br /><br>Co-primary endpoint is the absolute reduction of the duration of antibiotic<br /><br>therapy (quantitative version of the primary endpoint for estimation of effect<br /><br>size).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety endpoints: mortality, duration of hospitalization, recurrence of<br /><br>infection necessitating antibiotic therapy within the first month of life. </p><br>