N/A
N=121
Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT00926497 ↗Enrolled (actual)
121
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Antibiotic Treatment for More Than 72 Hours — 33; 55 participants — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Procalcitonin-guided decision making (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Luzerner Kantonsspital
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibiotic Treatment for More Than 72 Hours |
33; 55 | 0.002 sig |
| PRIMARY Absolute Duration of Antibiotic Therapy |
79.1; 101.5 | 0.012 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00926497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.