Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial|
- Antibiotic Treatment for More Than 72 Hours [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Absolute Duration of Antibiotic Therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||January 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Experimental: Procalcitonin group
Antibiotic therapy is discontinued when two consecutive Procalcitonin values are below predefined age-adjusted cut-off values. Antibiotic therapy could be prolonged despite fulfilled Procalcitonin criteria at the discretion of the attending physician.
Other: Procalcitonin-guided decision making
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis
No Intervention: Standard group
Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926497
|children's Hospital of Lucerne|
|Lucerne, Switzerland, 6000|
|Principal Investigator:||Martin Stocker, MD||Children's Hospital Lucerne, Switzerland|