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

• Conditions: Comparing Antibiotic Duration of Therapy

• Registration Number: NCT05756049
• Lead Sponsor: Methodist Health System

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

Study Timeline

• Study Start: 2022-11-29
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total days of antibiotic therapy	6 months	Actual antibiotic days and predicted antibiotic days (i.e., SAAR)

Trial Locations

Locations (1)

Methodist Richardson Medical Center; 🇺🇸 Dallas, Texas, United States