Procalcitonin for Stewardship in Respiratory Infections A Stewardship Project

NCT03109106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2018-09-27

No results posted yet for this study

Summary

Antibiotics are overused in hospitals nationwide, leading to unnecessary drug costs and adverse events. Antibiotic stewardship is now a national and international priority and regulatory authorities are mandating antibiotic stewardship programs in all hospitals. Respiratory infections account for a large percentage of antibiotic overuse. Procalcitonin has been shown to help providers significantly shorten the duration of antibiotic therapy in respiratory infections. As such, this institution seeks to evaluate the impact of PCT-guided antibiotic management on antibiotic use in subjects with acute Lower Respiratory Tract Infection (LRTI) with or without sepsis. Multiple studies have been conducted in Europe and demonstrate the safety of the PCT-guided antibiotic management in pneumonia as well as sepsis. This study will apply PCT-guided therapy to those populations in an all-US study evaluating patient outcomes along with safety and efficacy.

Conditions

  • LRTI

Interventions

DEVICE

PCT Arm

PCT-guided antibiotic therapy per study protocol

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2018-03-15
Completion
2018-03-15

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109106 on ClinicalTrials.gov