Pneumonia in the Intensive Care Unit (ICU) Setting
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| ClinicalTrials.gov Identifier: NCT02685930 |
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Recruitment Status :
Completed
First Posted : February 19, 2016
Last Update Posted : May 8, 2018
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Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Marin Kollef, Washington University School of Medicine
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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.
| 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 |
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 |
| Actual Enrollment : | 364 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Pneumonia in the Intensive Care Unit (ICU) Setting |
| Study Start Date : | January 2016 |
| Actual Primary Completion Date : | February 1, 2017 |
| Actual Study Completion Date : | February 1, 2017 |
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| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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)
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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. |
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
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
Locations
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Marin Kollef, MD | Washington University School of Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marin Kollef, M.D., FACP, FCCP, Professor of Medicine, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT02685930 |
| Other Study ID Numbers: |
201509075 |
| First Posted: | February 19, 2016 Key Record Dates |
| Last Update Posted: | May 8, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Marin Kollef, Washington University School of Medicine:
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invasive mechanical ventilation |
Additional relevant MeSH terms:
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Pneumonia Respiratory Insufficiency Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |