Neonatal Procalcitonin Intervention Study

Not Applicable

• Conditions: Sepsis
• Interventions: Other: Procalcitonin-guided decision making

• Registration Number: NCT00854932
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

In neonates, clinical signs and symptoms associated with early-onset sepsis are non-specific and currently available tests have poor positive and negative predictive values. The investigators hypothesize that procalcitonin (PCT) has a reliable negative predictive values to allow a reduction in duration of empiric antibiotic therapy in suspected neonatal early-onset sepsis with unchanged outcome. This study is designed as a multi-center, prospective, randomized intervention trial. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the probability of infection during hospitalisation. In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.

Detailed Description

Detailed description according our pilot study (see reference). This trial is designed to exclude a difference in rate of re-infection or death greater than 2%. Assuming a 2% reinfection/death rate in each group, 770 patients are required for a power of 80% at alpha=0.05. To allow for some unevaluable cases 800 per group will be included. Based on the data of the pilot study (see reference), with a number of 770 per group a difference between mean antibiotic therapy durations of 10 hours can be detected at two-sided alpha of 0.05 with a power of 95%.

Study Timeline

• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Study Start: 2009-06
• Primary Completion: 2015-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• Term and near term infants with a gestational age > 34 weeks
• Suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy
• Parental consent

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Exclusion Criteria

• Surgery in the first week of life
• Severe congenital malformations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCT group	Procalcitonin-guided decision making	In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PCT values are within the normal range.Antibiotic therapy can be continued despite fulfilled criteria at the discretion of the attending physician. These divesions from the stopping rules will be reported for further analysis.

Primary Outcome Measures

Name	Time	Method
The absolute reduction of the duration of antibiotic therapy with unchanged outcome	1 month	Unchanged outcome = proportion of infants with a recurrence of infection requiering additional courses of antibiotic therapy within 72 hours after ending antibiotic therapy and/or death in the first month of life

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalisation	1 month

Trial Locations

Locations (1)

children's Hospital of Lucerne; 🇨🇭 Lucerne, Switzerland