Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis
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|ClinicalTrials.gov Identifier: NCT00926497|
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : June 23, 2009
Last Update Posted : June 23, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Other: Procalcitonin-guided decision making||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||January 2007|
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
- Antibiotic Treatment for More Than 72 Hours [ Time Frame: 1 month ]
- Absolute Duration of Antibiotic Therapy [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926497
|children's Hospital of Lucerne|
|Lucerne, Switzerland, 6000|
|Principal Investigator:||Martin Stocker, MD||Children's Hospital Lucerne, Switzerland|