Overview

This trial is active, not recruiting.

Condition sepsis
Treatment procalcitonin-guided decision making
Sponsor Luzerner Kantonsspital
Collaborator Kantonsspital Winterthur KSW
Start date June 2009
End date May 2015
Trial size 1600 participants
Trial identifier NCT00854932, NeoPInS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
procalcitonin-guided decision making Procalcitonin-guided duration of antibiotic therapy
In the PCT group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive PDT values are within the normal range.
(No Intervention)
The duration of antibiotic treatment in the standard group is based on the attending physician's assessment of the risk of classification: infection unlikely for 36-72 hours, infection possible for 5-7 days, infection probable of proven for 7-21 days depending on clinical course, laboratory values and positive cultures.

Primary Outcomes

Measure
The absolute reduction of the duration of antibiotic therapy with unchanged outcome
time frame: 1 month

Secondary Outcomes

Measure
Duration of hospitalisation
time frame: 1 month

Eligibility Criteria

Male or female participants up to 3 days old.

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 Exclusion Criteria: - Surgery in the first week of life - Severe congenital malformations

Additional Information

Official title Effect of Procalcitonin-guided Decision Making on Duration of Antibiotic Therapy in Suspected Neonatal Early-onset Sepsis: Multicenter Prospective Randomized Intervention Study
Principal investigator Martin Stocker, MD
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%.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Luzerner Kantonsspital.