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

NCT00926497 | Completed Results DMC

• 1 other identifier: PCTStocker
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

antibiotic therapy; early-onset sepsis; interventions study; procalcitonin; term and near-term neonates

Outcome Measures

Primary Outcomes (2)

• Antibiotic Treatment for More Than 72 Hours

  Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)

  1 month

• Absolute Duration of Antibiotic Therapy

  Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)

  1 month

Study Arms (2)

Procalcitonin group

EXPERIMENTAL

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

Standard group

NO INTERVENTION

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

Interventions

Procalcitonin-guided decision making OTHER

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

Procalcitonin group

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Surgery in the first 3 days of life
• Severe congenital malformations
• Chromosomal abnormalities

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

children's Hospital of Lucerne

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The samll sample size does not allow to prove the safety of our Procalcitonin-guided strategy. Second, because of our single center setting, our results cannot be easily be extrapolated.

Results Point of Contact

• Title: Martin Stocker, MD
• Organization: Children's Hospital of Lucerne

martin.stocker@ksl.ch

0041412051288

Study Officials

• Martin Stocker, MD

  Children's Hospital Lucerne, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: June 23, 2009
• Results First Posted: June 23, 2009

Record last verified: 2009-05

Locations

CH (1)