Clinical trial NCT05756049: Procalcitonin Protocol Use to Guide Antibiotic Therapy Duration in the Intensive Care Unit
Official title: Procalcitonin Protocol Use to Guide Antibiotic Therapy Duration in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Comparing Antibiotic Duration of Therapy
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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

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
    * 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

Primary outcomes:
measure: Total days of antibiotic therapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Wendy Richow, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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