Clinical trial NCT02685930: Pneumonia in the Intensive Care Unit (ICU) Setting
Official title: Pneumonia in the Intensive Care Unit (ICU) Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Respiratory Failure
Keywords: invasive mechanical ventilation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: In-hospital mortality
timeFrame: maxiumum of 12 months
Secondary outcomes:
measure: Hospital length of stay
timeFrame: maximum of 12 months
measure: ICU length of stay
timeFrame: maximum of 12 months
measure: Days of invasive mechanical ventilation
timeFrame: maximum of 12 months
measure: Total days of antibiotic, antiviral, and antifungal administration (collected both as a total days of therapy and by individual agent)
timeFrame: maximum of 12 months (including planned course of antibiotics to be continued upon discharge)
measure: Total days of septic shock as defined by the requirement of vasopressor therapy for maintaining a MAP > 60
timeFrame: maximum of 12 months
measure: Occurrence of ventilator-associated events
timeFrame: maximum of 12 months
measure: Disposition
timeFrame: maximum of 12 months
measure: 90 day readmission rate
timeFrame: 90 days from time of discharge from index hospitalization
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Marin Kollef, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shorr AF, Zilberberg MD, Reichley R, Kan J, Hoban A, Hoffman J, Micek ST, Kollef MH. Readmission following hospitalization for pneumonia: the impact of pneumonia type and its implication for hospitals. Clin Infect Dis. 2013 Aug;57(3):362-7. doi: 10.1093/cid/cit254. Epub 2013 May 15.
citation: Magill SS, Klompas M, Balk R, Burns SM, Deutschman CS, Diekema D, Fridkin S, Greene L, Guh A, Gutterman D, Hammer B, Henderson D, Hess D, Hill NS, Horan T, Kollef M, Levy M, Septimus E, VanAntwerpen C, Wright D, Lipsett P. Developing a new, national approach to surveillance for ventilator-associated events*. Crit Care Med. 2013 Nov;41(11):2467-75. doi: 10.1097/CCM.0b013e3182a262db.
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