Pneumonia in the Intensive Care Unit (ICU) Setting
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|ClinicalTrials.gov Identifier: NCT02685930|
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : November 11, 2016
|Condition or disease||Intervention/treatment|
|Pneumonia Respiratory Failure||Behavioral: Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Pneumonia in the Intensive Care Unit (ICU) Setting|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2017|
Pneumonia without ICU stewardship involvement
Patients receiving >24 hours of invasive mechanical ventilation for pneumonia-related respiratory failure. Antibiotic choice and duration of therapy will not be influenced by the dedicated ICU stewardship team.
Pneumonia with ICU stewardship involvement
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)
Behavioral: Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy
ICU stewardship team will provide recommendations to the ICU team regarding antibiotic de-escalation and duration of therapy in attempts of improving antibiotic stewardship practices without compromising patient outcomes.Recommendations will be based on patient showing clinical improvement combined with microbial culture data.
- In-hospital mortality [ Time Frame: maxiumum of 12 months ]
- Hospital length of stay [ Time Frame: maximum of 12 months ]
- ICU length of stay [ Time Frame: maximum of 12 months ]
- Days of invasive mechanical ventilation [ Time Frame: maximum of 12 months ]
- Total days of antibiotic, antiviral, and antifungal administration (collected both as a total days of therapy and by individual agent) [ Time Frame: 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.
- Total days of septic shock as defined by the requirement of vasopressor therapy for maintaining a MAP > 60 [ Time Frame: 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 [ Time Frame: maximum of 12 months ]tracheostomy placement, VAP, pneumothorax while on ventilator
- Disposition [ Time Frame: 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.
- 90 day readmission rate [ Time Frame: 90 days from time of discharge from index hospitalization ]readmission all causes at 90 days post-discharge from index hospitalization
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685930
|Contact: Marin Kollef, MDemail@example.com|
|Contact: Tracy Trupka, MDfirstname.lastname@example.org|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Contact: Marin Kollef, MD 314-454-8244 email@example.com|
|Contact: Tracy Trupka, MD 636-368-7257 firstname.lastname@example.org|
|Sub-Investigator: Kristen Fischer, MD|
|Sub-Investigator: Mollie Gower, PharmD|
|Principal Investigator:||Marin Kollef, MD||Washington University School of Medicine|