Procalcitonin Protocol Use to Guide Antibiotic Therapy Duration in the Intensive Care Unit

Sponsor
Methodist Health System (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05756049
Collaborator
(none)
208
1
12
17.3

Study Details

Study Description

Brief Summary

To compare and contrast antibiotic use and its effects on patient outcomes before and after the implementation of a PCT protocol in the ICU at Methodist Richardson Medical Center (MRMC).

Condition or Disease Intervention/Treatment Phase
  • Other: compare antibiotic duration of therapy

Detailed Description

Based on previous clinical trials, current literature supports the use of PCT levels in combination with clinical assessments to help determine optimal antibiotic therapy. On May 30, 2022, MRMC launched a PCT protocol in the ICU that allows clinical pharmacy specialists to order PCT levels in certain bacterial infections. In order to determine the effects of the protocol, a retrospective quasi-experimental review will be conducted

Study Design

Study Type:
Observational
Anticipated Enrollment :
208 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Procalcitonin Protocol Use to Guide Antibiotic Therapy Duration in the Intensive Care Unit
Actual Study Start Date :
Nov 29, 2022
Anticipated Primary Completion Date :
Nov 29, 2023
Anticipated Study Completion Date :
Nov 29, 2023

Outcome Measures

Primary Outcome Measures

  1. Total days of antibiotic therapy [6 months]

    Actual antibiotic days and predicted antibiotic days (i.e., SAAR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • ● Patients aged 18 years or older

  • Patients being monitored on the PCT protocol

  • ICU location status for at least part of the admission

  • Received antibiotics in the ICU for a diagnosis of:

  • Community-acquired pneumonia

  • Hospital-acquired pneumonia

  • Ventilator-associated pneumonia

  • Sepsis and/or septic shock

  • Uncomplicated bacteremia with known source

  • Chronic obstructive pulmonary disorder exacerbation

  • Asthma exacerbation

Exclusion Criteria:
  • Received antibiotics in the ICU for a diagnosis of:

  • Uncomplicated skin and soft tissue infections

  • Abscess

  • Empyema

  • Bacterial infections that require prolonged antibiotic therapy (e.g., osteomyelitis, endocarditis, tuberculosis, etc.)

  • Intra-abdominal infection

  • Urinary tract infection

  • Bacterial meningitis

  • Estimated Glomerular Filtration Rate <15 mL/min

  • Requiring renal replacement therapy

  • Status post cardiac arrest/target temperature management

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Richardson Medical Center Dallas Texas United States 75082

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Wendy Richow, PharmD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05756049
Other Study ID Numbers:
  • 117.PHA.2022.R
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 6, 2023