Pneumonia in the Intensive Care Unit (ICU) Setting

Completed

• Conditions: Respiratory Failure; Pneumonia
• Interventions: Behavioral: Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy

• Registration Number: NCT02685930
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this observational study is to collect prospective data on the occurrence of bacterial and viral pneumonia in the ICU setting. Current classification systems for pneumonia promote over treatment with antibiotics as they do not specifically recognize the presence of culture-negative and viral pneumonia. The investigators will collect data to determine if a novel pneumonia classification system can be developed that more accurately links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia, antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to clinical outcomes. Additionally, the investigators will collect data on the practice of antimicrobial stewardship in the ICU setting to determine if further improvements in antibiotic practices can be accomplished in the future.

Detailed Description

The investigators will be prospectively collecting data on patients admitted to the 8300 and 8400 medical intensive care units at Barnes-Jewish Hospital requiring invasive mechanical ventilation for support in respiratory failure from pneumonia. Data will be collected on patients admitted from 1/2016-12/2016. The investigators will be collecting initial patient characteristic data as well as reviewing microbial specimen results (tracheal aspirate, bronchial alveolar lavage, viral multiplex, blood cultures) and antibiotic usage in real time. The investigators will identify any changes in antibiotic usage demonstrated with the advising of the ICU antibiotic stewardship team.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-15
• Study First Posted: 2016-02-19
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-05
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

• age 18+, admitted for 8300 or 8400 medical ICU between 1/2016 and 12/2016 for respiratory failure from pneumonia, requirement of > 24 hours of invasive mechanical ventilatory support for pneumonia

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Exclusion Criteria

• Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids > 20mg/day Prednisone equivalent, other home immunosuppressants, solid organ or bone marrow transplant patients, cystic fibrosis, bronchiectasis, active malignancy, receiving chemotherapy or radiation therapy within the past 3 months, hematologic malignancy
• Chronic ventilator dependence

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pneumonia with ICU stewardship involvement	Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy	Patients receiving \>24 hours of invasive mechanical ventilation for pneumonia-related respiratory failure. Recommendations for antibiotic choice and duration of therapy will be provided by the dedicated ICU stewardship team (consisting of pulmonary fellows and ICU pharmacists)

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	maxiumum of 12 months

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	maximum of 12 months
Hospital length of stay	maximum of 12 months
Total days of antibiotic, antiviral, and antifungal administration (collected both as a total days of therapy and by individual agent)	maximum of 12 months (including planned course of antibiotics to be continued upon discharge)	The investigators will collect this information by reviewing the electronic medical record which delineates dates and times of each of the medications administered to a participant by nursing staff. The specific dates as well as total consecutive calendar days of each antibiotic administered will be charted in a database for further analysis. Antibiotics will be ranked for spectrum of activity based on microbial coverage as per the Barnes-Jewish Hospital antibiogram most recently published in 2014. De-escalation will be defined as a decrease in number and/or spectrum of antimicrobials administered. Antibiotics, antiviral, antifungals including those which fall into the following classes will be recorded: Penicillins, Floroquinalones, Macrolides, Vancomycin, Linezolid, Cephalosporins, Carbapenems, Monobactams, Aztreonam, Aminoglycocides, Tetracyclines, Metronidazole, non-specific antifungals, Azoles \& derivatives, antivirals.
Days of invasive mechanical ventilation	maximum of 12 months
90 day readmission rate	90 days from time of discharge from index hospitalization	readmission all causes at 90 days post-discharge from index hospitalization
Total days of septic shock as defined by the requirement of vasopressor therapy for maintaining a MAP > 60	maximum of 12 months	The electronic medical record will be utilized to determine the number of days for which a participant required vasopressor therapy for blood pressure support. Norepinephrine, Vasopressin, and Phenylephrine are considered vasopressors for this study.
Occurrence of ventilator-associated events	maximum of 12 months	tracheostomy placement, VAP, pneumothorax while on ventilator
Disposition	maximum of 12 months	Discharge documentation and social work notes will be reviewed to determine if the patient was discharged to home, an extended care facility/skilled nursing facility, hospice (at home or facility), long term acute care hospital, psychiatric ward, other hospital, or inpatient rehabilitation center. If the patient died in the hospital prior any discharge, this will be documented as the disposition.

Trial Locations

Locations (1)

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States