Pneumonia in the Intensive Care Unit (ICU) Setting

May 5, 2018 updated by: Marin Kollef, Washington University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
In-hospital mortality
Time Frame: maxiumum of 12 months
maxiumum of 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: maximum of 12 months
maximum of 12 months
ICU length of stay
Time Frame: maximum of 12 months
maximum of 12 months
Days of invasive mechanical ventilation
Time Frame: maximum of 12 months
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.
maximum of 12 months (including planned course of antibiotics to be continued upon discharge)
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.
maximum of 12 months
Occurrence of ventilator-associated events
Time Frame: maximum of 12 months
tracheostomy placement, VAP, pneumothorax while on ventilator
maximum of 12 months
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.
maximum of 12 months
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
90 days from time of discharge from index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201509075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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