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

NCT ID: NCT00926497

Last Updated: 2009-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2007-01-31

Brief 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.

Detailed 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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Procalcitonin-guided decision making

Intervention Type: OTHER

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

Standard group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Procalcitonin-guided decision making

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

Intervention Type: OTHER

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

• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Children's Hospital Lucerne

Principal Investigators

Martin Stocker, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Lucerne, Switzerland

Locations

children's Hospital of Lucerne

Lucerne, , Switzerland

Countries

Switzerland

Other Identifiers

PCTStocker

Identifier Type: -

Identifier Source: org_study_id