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

Sepsis Clinical Trial

Official title:

Use of Procalcitonin-Guided Decision Making to Shorten Antibiotic Therapy in Suspected Neonatal Early-Onset Sepsis: Prospective Randomized Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926497
• Other study ID #: PCTStocker
• Status: Completed
• Phase: N/A
• First received: January 16, 2009
• Last updated: May 4, 2009
• Start date: June 2005
• Est. completion date: January 2007

Study information

• Verified date: May 2009
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

This single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the Children's Hospital of Lucerne, Switzerland between June 1, 2005 and December 31, 2006. All term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to Procalcitonin-guided treatment (Procalcitonin-group). Minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the Procalcitonin group antibiotic therapy was discontinued when two consecutive Procalcitonin values were below predefined age-adjusted cut-off values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Procalcitonin-guided decision making
Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early onset sepsis

Locations

Country	Name	City	State
Switzerland	children's Hospital of Lucerne	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic Treatment for More Than 72 Hours		1 month	Yes
Primary	Absolute Duration of Antibiotic Therapy		1 month	Yes