Pneumonia in the Intensive Care Unit (ICU) Setting

NCT ID: NCT02685930

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-02-01

Brief Summary

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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

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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.

Conditions

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Pneumonia Respiratory Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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)

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Marin Kollef

M.D., FACP, FCCP, Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marin Kollef, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Vidaur L, Planas K, Sierra R, Dimopoulos G, Ramirez A, Lisboa T, Rello J. Ventilator-associated pneumonia: impact of organisms on clinical resolution and medical resources utilization. Chest. 2008 Mar;133(3):625-32. doi: 10.1378/chest.07-2020. Epub 2008 Jan 15.

Reference Type BACKGROUND
PMID: 18198250 (View on PubMed)

Kollef MH, Chastre J, Clavel M, Restrepo MI, Michiels B, Kaniga K, Cirillo I, Kimko H, Redman R. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care. 2012 Nov 13;16(6):R218. doi: 10.1186/cc11862.

Reference Type BACKGROUND
PMID: 23148736 (View on PubMed)

Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.

Reference Type BACKGROUND
PMID: 11934711 (View on PubMed)

Charlson ME, Sax FL, MacKenzie CR, Fields SD, Braham RL, Douglas RG Jr. Assessing illness severity: does clinical judgment work? J Chronic Dis. 1986;39(6):439-52. doi: 10.1016/0021-9681(86)90111-6.

Reference Type BACKGROUND
PMID: 3086355 (View on PubMed)

Dharmarajan K, Hsieh AF, Lin Z, Bueno H, Ross JS, Horwitz LI, Barreto-Filho JA, Kim N, Bernheim SM, Suter LG, Drye EE, Krumholz HM. Diagnoses and timing of 30-day readmissions after hospitalization for heart failure, acute myocardial infarction, or pneumonia. JAMA. 2013 Jan 23;309(4):355-63. doi: 10.1001/jama.2012.216476.

Reference Type BACKGROUND
PMID: 23340637 (View on PubMed)

Tang VL, Halm EA, Fine MJ, Johnson CS, Anzueto A, Mortensen EM. Predictors of rehospitalization after admission for pneumonia in the veterans affairs healthcare system. J Hosp Med. 2014 Jun;9(6):379-83. doi: 10.1002/jhm.2184. Epub 2014 Mar 19.

Reference Type BACKGROUND
PMID: 24648401 (View on PubMed)

Cabre M, Serra-Prat M, Force L, Almirall J, Palomera E, Clave P. Oropharyngeal dysphagia is a risk factor for readmission for pneumonia in the very elderly persons: observational prospective study. J Gerontol A Biol Sci Med Sci. 2014 Mar;69(3):330-7. doi: 10.1093/gerona/glt099. Epub 2013 Jul 5.

Reference Type BACKGROUND
PMID: 23833199 (View on PubMed)

Iregui M, Ward S, Sherman G, Fraser VJ, Kollef MH. Clinical importance of delays in the initiation of appropriate antibiotic treatment for ventilator-associated pneumonia. Chest. 2002 Jul;122(1):262-8. doi: 10.1378/chest.122.1.262.

Reference Type BACKGROUND
PMID: 12114368 (View on PubMed)

Micek ST, Lang A, Fuller BM, Hampton NB, Kollef MH. Clinical implications for patients treated inappropriately for community-acquired pneumonia in the emergency department. BMC Infect Dis. 2014 Feb 5;14:61. doi: 10.1186/1471-2334-14-61.

Reference Type BACKGROUND
PMID: 24499035 (View on PubMed)

Kollef MH, Shorr A, Tabak YP, Gupta V, Liu LZ, Johannes RS. Epidemiology and outcomes of health-care-associated pneumonia: results from a large US database of culture-positive pneumonia. Chest. 2005 Dec;128(6):3854-62. doi: 10.1378/chest.128.6.3854.

Reference Type BACKGROUND
PMID: 16354854 (View on PubMed)

Micek ST, Kollef KE, Reichley RM, Roubinian N, Kollef MH. Health care-associated pneumonia and community-acquired pneumonia: a single-center experience. Antimicrob Agents Chemother. 2007 Oct;51(10):3568-73. doi: 10.1128/AAC.00851-07. Epub 2007 Aug 6.

Reference Type BACKGROUND
PMID: 17682100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23677872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24162674 (View on PubMed)

Trupka T, Fisher K, Micek ST, Juang P, Kollef MH. Enhanced antimicrobial de-escalation for pneumonia in mechanically ventilated patients: a cross-over study. Crit Care. 2017 Jul 15;21(1):180. doi: 10.1186/s13054-017-1772-4.

Reference Type DERIVED
PMID: 28709439 (View on PubMed)

Other Identifiers

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201509075

Identifier Type: -

Identifier Source: org_study_id

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