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Trial record 1 of 1 for:    trupka | pneumonia | United States, Missouri
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Pneumonia in the Intensive Care Unit (ICU) Setting

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Marin Kollef, Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Marin Kollef, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02685930
First received: January 26, 2016
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
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
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pneumonia in the Intensive Care Unit (ICU) Setting

Resource links provided by NLM:


Further study details as provided by Marin Kollef, Washington University School of Medicine:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: maxiumum of 12 months ]

Secondary Outcome Measures:
  • 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
Microbiological: tracheal aspirate, bronchialalveolar lavage, blood cultures, viral PCR multiplex from respiratory specimen Bronchialalveolar lavage: Cell count and differential

Estimated Enrollment: 200
Study Start Date: January 2016
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02685930

Contacts
Contact: Marin Kollef, MD 314-454-8244 mkollef@dom.wustl.edu
Contact: Tracy Trupka, MD 636-368-7257 ttrupka@dom.wustl.edu

Locations
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Marin Kollef, MD    314-454-8244    mkollef@dom.wustl.edu   
Contact: Tracy Trupka, MD    636-368-7257    ttrupka@dom.wustl.edu   
Sub-Investigator: Kristen Fischer, MD         
Sub-Investigator: Mollie Gower, PharmD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Marin Kollef, MD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Marin Kollef, M.D., FACP, FCCP, Professor of Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02685930     History of Changes
Other Study ID Numbers: 201509075
Study First Received: January 26, 2016
Last Updated: November 10, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marin Kollef, Washington University School of Medicine:
invasive mechanical ventilation

Additional relevant MeSH terms:
Pneumonia
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on September 21, 2017