CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 271 enrolled
Drug / intervention
Procalcitonin-Guided Antimicrobial Stewardship +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03440918
NCT03440918N/ACompleted

Prospective, Randomized Controlled Trial to Evaluate the Impact of a Procalcitonin Testing and Treatment Algorithm on Antibiotic Use and Outcomes in the Pediatric Intensive Care Unit

Vanderbilt University Medical Center·interventional·Posted Feb 22, 2018·Updated Apr 22, 2020

In Brief

A clinical study evaluating Procalcitonin-Guided Antimicrobial Stewardship and Baseline Antimicrobial Stewardship for Sepsis and 2 related conditions. Completed, enrolled 271 participants across 1 site.

Detailed Summary

The timely use of antibiotics can reduce morbidity and mortality associated with bacterial infections, particularly in the intensive care unit setting (ICU). Long courses of antibiotics, however, are associated with the emergence of multi-drug resistant organisms and antibiotic-associated adverse events, such as C. difficile infections. Thus, antibiotic de-escalation is an important goal of antimicrobial stewardship programs. Procalcitonin (PCT) has been investigated as a biomarker for critically ill adult patients with bacterial infection, particularly pneumonia and sepsis. The proposed project will evaluate whether a PCT testing and treatment algorithm, implemented through daily antimicrobial stewardship audit and feedback, can promote early and safe antibiotic de-escalation in the pediatric ICU.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartFeb 12, 2018
Primary CompletionMay 11, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.4 years ago

Interventions

Procalcitonin-Guided Antimicrobial Stewardshipother

In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.

Baseline Antimicrobial Stewardshipother

Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.