Neonatal Procalcitonin Intervention Study

2014-08-27 03:23:54 | BioPortfolio


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 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 Design

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




Procalcitonin-guided decision making


children's Hospital of Lucerne




Luzerner Kantonsspital

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:23:54-0400

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Medical and Biotech [MESH] Definitions

Mathematical or statistical procedures used as aids in making a decision. They are frequently used in medical decision-making.

Use of an interactive computer system designed to assist the physician or other health professional in choosing between certain relationships or variables for the purpose of making a diagnostic or therapeutic decision.

A scenario in decision analysis in which two individuals motivated entirely by self-preservation at the expense of the other, end up in a worse state than if they had cooperated with each other in the decision-making process.

The process of making a selective intellectual judgment when presented with several complex alternatives consisting of several variables, and usually defining a course of action or an idea.

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