N/A Completed N=121 Randomized Treatment

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

Sepsis

Source: ClinicalTrials.gov NCT00926497 ↗

Enrolled (actual)

121

Serious AEs

—

Results posted

Jun 2009

Primary outcomePrimary: Antibiotic Treatment for More Than 72 Hours — 33; 55 participants — p=0.002

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.