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Pneumonia in the Intensive Care Unit (ICU) Setting

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ClinicalTrials.gov Identifier: NCT02685930
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Marin Kollef, Washington University School of Medicine

Tracking Information
First Submitted Date January 26, 2016
First Posted Date February 19, 2016
Last Update Posted Date May 8, 2018
Study Start Date January 2016
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2016)
In-hospital mortality [ Time Frame: maxiumum of 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02685930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 18, 2016)
  • 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
Original Secondary Outcome Measures
 (submitted: February 15, 2016)
  • 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 ]
    home, rehab, SNF, death
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pneumonia in the Intensive Care Unit (ICU) Setting
Official Title Pneumonia in the Intensive Care Unit (ICU) Setting
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Microbiological: tracheal aspirate, bronchialalveolar lavage, blood cultures, viral PCR multiplex from respiratory specimen Bronchialalveolar lavage: Cell count and differential
Sampling Method Non-Probability Sample
Study Population Patients in the 8300 and 8400 medical intensive care units at Barnes-Jewish Hospital with respiratory failure from pneumonia requiring invasive mechanical ventilation.
Condition
  • Pneumonia
  • Respiratory Failure
Intervention 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.
Study Groups/Cohorts
  • 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)
    Intervention: Behavioral: Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 5, 2018)
364
Original Estimated Enrollment
 (submitted: February 15, 2016)
200
Actual Study Completion Date February 1, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02685930
Other Study ID Numbers 201509075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marin Kollef, Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Marin Kollef, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date May 2018