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

Luzerner Kantonsspital

Status: Completed

Conditions: Sepsis

Treatments: Other: Procalcitonin-guided decision making

Study type: Interventional

Funder types: Other

Identifiers

NCT00926497

PCTStocker

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Procalcitonin group

Experimental group

Description:

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.

Treatment:

Other: Procalcitonin-guided decision making

Standard group

No Intervention group

Description:

Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters