Pneumonia in the Intensive Care Unit (ICU) Setting

NCT02685930 | Completed

• 1 other identifier: 201509075
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Respiratory Failure

Keywords

invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  maxiumum of 12 months

Secondary Outcomes (8)

• Hospital length of stay

  maximum of 12 months

• ICU length of stay

  maximum of 12 months

• Days of invasive mechanical ventilation

  maximum of 12 months

• Total days of antibiotic, antiviral, and antifungal administration (collected both as a total days of therapy and by individual agent)

  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

  maximum of 12 months

Study Arms (2)

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

Interventions

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.

Pneumonia with ICU stewardship involvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (14)

• 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.

  PMID: 18198250 BACKGROUND

• 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.

  PMID: 23148736 BACKGROUND

• 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.

  PMID: 11934711 BACKGROUND

• 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.

  PMID: 3086355 BACKGROUND

• 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.

  PMID: 23340637 BACKGROUND

• 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.

  PMID: 24648401 BACKGROUND

• 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.

  PMID: 23833199 BACKGROUND

• 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.

  PMID: 12114368 BACKGROUND

• 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.

  PMID: 24499035 BACKGROUND

• 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.

  PMID: 16354854 BACKGROUND

• 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.

  PMID: 17682100 BACKGROUND

• 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.

  PMID: 23677872 BACKGROUND

• 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.

  PMID: 24162674 BACKGROUND

• 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.

  PMID: 28709439 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiological: tracheal aspirate, bronchialalveolar lavage, blood cultures, viral PCR multiplex from respiratory specimen Bronchialalveolar lavage: Cell count and differential

MeSH Terms

Conditions

Pneumonia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Marin Kollef, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., FACP, FCCP, Professor of Medicine

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 19, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)