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Clinical Trials/NCT05756049
NCT05756049
Enrolling By Invitation
Not Applicable

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

Methodist Health System1 site in 1 country208 target enrollmentNovember 29, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Comparing Antibiotic Duration of Therapy
Sponsor
Methodist Health System
Enrollment
208
Locations
1
Primary Endpoint
Total days of antibiotic therapy
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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).

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

Registry
clinicaltrials.gov
Start Date
November 29, 2022
End Date
November 29, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Received antibiotics in the ICU for a diagnosis of:
  • Uncomplicated skin and soft tissue infections
  • 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

Outcomes

Primary Outcomes

Total days of antibiotic therapy

Time Frame: 6 months

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

Study Sites (1)

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