Skip to main content
OpenTrials
Completed

NCT Number: NCT02685930

Pneumonia in the Intensive Care Unit (ICU) Setting

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pneumonia Infections Lung Diseases Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy

Behavioral

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.

Primary outcomes

  1. In-hospital mortality

    Time frame: maxiumum of 12 months

Secondary outcomes

  1. Hospital length of stay

    Time frame: maximum of 12 months

  2. ICU length of stay

    Time frame: maximum of 12 months

  3. Days of invasive mechanical ventilation

    Time frame: maximum of 12 months

  4. 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.

  5. 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.

  6. Occurrence of ventilator-associated events

    Time frame: maximum of 12 months

    tracheostomy placement, VAP, pneumothorax while on ventilator

  7. 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.

  8. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2016
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.