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This is a non-inferiority study evaluating clinical improvement rate when using MRSA nasal swabs to guide discontinuation of vancomycin for empiric coverage for MRSA pneumonia.
Current clinical guidelines recommend including vancomycin in initial empiric therapy if risk factors for MRSA infection are present, or there is a high incidence of MRSA locally. Prolonged exposure to vancomycin, however, has been linked with the risk of vancomycin-associated kidney failure. Studies have reported that a MRSA nasal swab may be used to predict the presence of MRSA pneumonia. Specifically, pneumonia patients with negative MRSA nasal swabs are 95-99% likely to not have pneumonia due to MRSA. There is limited data, however, evaluating the use of a MRSA nasal swab to guide vancomycin therapy. Accordingly, in this study, pneumonia patients in the intervention arm will have empiric vancomycin discontinued following a negative MRSA nasal swab. In the control arm, patients vancomycin will not be discontinued based on the MRSA nasal swab result. The rate of clinical resolution will be compared between these two study arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Patients admitted for pneumonia whose MRSA nasal swab is negative for MRSA, and empiric vancomycin is discontinued within 24 hours of the MRSA nasal swab results being documented in the electronic health record. | ||
| Treatment Group B | Patients admitted for pneumonia whose empiric vancomycin is continued for ≥24 hours after electronic health record documentation of negative MRSA nasal swab results. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Clinical Improvement | Rate of clinical improvement following 7 days of antibiotic therapy for pneumonia. Clinical improvement rate is defined as the percentage of patients who had clinical documentation of improvement or resolution of all clinical signs and symptoms of pneumonia present at the time of pneumonia diagnosis.
| Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Date of admission to date of discharge from the hospital | During patient hospital stay for up to 6 months |
| In-hospital mortality | Number of deaths |
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Inclusion Criteria:
Exclusion Criteria:
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All patients admitted to Charleston Area Medical Center through the Emergency Department with a diagnosis of pneumonia will be evaluated for potential enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Audis Bethea, PharmD, BCPS | CAMC Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18992647 | Background | Edwards JR, Peterson KD, Andrus ML, Dudeck MA, Pollock DA, Horan TC; National Healthcare Safety Network Facilities. National Healthcare Safety Network (NHSN) Report, data summary for 2006 through 2007, issued November 2008. Am J Infect Control. 2008 Nov;36(9):609-26. doi: 10.1016/j.ajic.2008.08.001. No abstract available. | |
| 9397368 |
| Label | URL |
|---|---|
| Pneumonia." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 06 Oct. 2016. Web. 18 Jan. 2017 | View source |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| During patient hospital stay for up to 6 months |
| Rate of vancomycin-associated kidney injury defined as a 50% increase in serum creatinine or at least two consecutive increases in serum creatinine by 0.5 mg/dL after at least 48 hours of vancomycin therapy. | Number of kidney injuries following administration of vancomycin | Time between vancomycin administration and discharge from hospital for up to 6 months. |
| Hospital complications, such as MRSA bacteremia and septic shock | Number of MRSA bacteremia and septic shock patients whose MRSA nasal swab is negative and have MRSA pneumonia | During patient hospital stay for up tp 6 months |
| Billing cost associated with vancomycin therapy and laboratory monitoring | Total charges associated with vancomycin therapy and laboratory monitoring | During patient hospital stay for up to 6 months |
| Greenaway CA, Embil J, Orr PH, McLeod J, Dyck B, Nicolle LE. Nosocomial pneumonia on general medical and surgical wards in a tertiary-care hospital. Infect Control Hosp Epidemiol. 1997 Nov;18(11):749-56. doi: 10.1086/647529. |
| 9613899 | Background | Cook DJ, Kollef MH. Risk factors for ICU-acquired pneumonia. JAMA. 1998 May 27;279(20):1605-6. doi: 10.1001/jama.279.20.1605. No abstract available. |
| 7634921 | Background | Craven DE, Steger KA. Epidemiology of nosocomial pneumonia. New perspectives on an old disease. Chest. 1995 Aug;108(2 Suppl):1S-16S. doi: 10.1378/chest.108.2_supplement.1s. No abstract available. |
| 23999949 | Background | Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763. |
| 18462093 | Background | Rubinstein E, Kollef MH, Nathwani D. Pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2008 Jun 1;46 Suppl 5:S378-85. doi: 10.1086/533594. |
| 21208910 | Background | Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4. |
| 27925784 | Background | Erb CT, Patel B, Orr JE, Bice T, Richards JB, Metersky ML, Wilson KC, Thomson CC. Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Dec;13(12):2258-2260. doi: 10.1513/AnnalsATS.201608-641CME. No abstract available. |
| 23165462 | Background | van Hal SJ, Paterson DL, Lodise TP. Systematic review and meta-analysis of vancomycin-induced nephrotoxicity associated with dosing schedules that maintain troughs between 15 and 20 milligrams per liter. Antimicrob Agents Chemother. 2013 Feb;57(2):734-44. doi: 10.1128/AAC.01568-12. Epub 2012 Nov 19. |
| 19596879 | Background | Harigaya Y, Bulitta JB, Forrest A, Sakoulas G, Lesse AJ, Mylotte JM, Tsuji BT. Pharmacodynamics of vancomycin at simulated epithelial lining fluid concentrations against methicillin-resistant Staphylococcus aureus (MRSA): implications for dosing in MRSA pneumonia. Antimicrob Agents Chemother. 2009 Sep;53(9):3894-901. doi: 10.1128/AAC.01585-08. Epub 2009 Jul 13. |
| 19106348 | Background | Rybak M, Lomaestro B, Rotschafer JC, Moellering R Jr, Craig W, Billeter M, Dalovisio JR, Levine DP. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009 Jan 1;66(1):82-98. doi: 10.2146/ajhp080434. No abstract available. |
| 21576448 | Background | Minejima E, Choi J, Beringer P, Lou M, Tse E, Wong-Beringer A. Applying new diagnostic criteria for acute kidney injury to facilitate early identification of nephrotoxicity in vancomycin-treated patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3278-83. doi: 10.1128/AAC.00173-11. Epub 2011 May 16. |
| 20103028 | Background | Hazlewood KA, Brouse SD, Pitcher WD, Hall RG. Vancomycin-associated nephrotoxicity: grave concern or death by character assassination? Am J Med. 2010 Feb;123(2):182.e1-7. doi: 10.1016/j.amjmed.2009.05.031. |
| 9249217 | Background | Hiramatsu K, Hanaki H, Ino T, Yabuta K, Oguri T, Tenover FC. Methicillin-resistant Staphylococcus aureus clinical strain with reduced vancomycin susceptibility. J Antimicrob Chemother. 1997 Jul;40(1):135-6. doi: 10.1093/jac/40.1.135. No abstract available. |
| 20962147 | Background | Pitz AM, Yu F, Hermsen ED, Rupp ME, Fey PD, Olsen KM. Vancomycin susceptibility trends and prevalence of heterogeneous vancomycin-intermediate Staphylococcus aureus in clinical methicillin-resistant S. aureus isolates. J Clin Microbiol. 2011 Jan;49(1):269-74. doi: 10.1128/JCM.00914-10. Epub 2010 Oct 20. |
| 21976769 | Background | Richter SS, Satola SW, Crispell EK, Heilmann KP, Dohrn CL, Riahi F, Costello AJ, Diekema DJ, Doern GV. Detection of Staphylococcus aureus isolates with heterogeneous intermediate-level resistance to vancomycin in the United States. J Clin Microbiol. 2011 Dec;49(12):4203-7. doi: 10.1128/JCM.01152-11. Epub 2011 Oct 5. |
| 25554549 | Background | Tilahun B, Faust AC, McCorstin P, Ortegon A. Nasal colonization and lower respiratory tract infections with methicillin-resistant Staphylococcus aureus. Am J Crit Care. 2015 Jan;24(1):8-12. doi: 10.4037/ajcc2015102. |
| 25991589 | Background | Hiett J, Patel RK, Tate V, Smulian G, Kelly A. Using active methicillin-resistant Staphylococcus aureus surveillance nasal swabs to predict clinical respiratory culture results. Am J Health Syst Pharm. 2015 Jun 1;72(11 Suppl 1):S20-4. doi: 10.2146/ajhp140820. |
| 2024824 | Background | Pugin J, Auckenthaler R, Mili N, Janssens JP, Lew PD, Suter PM. Diagnosis of ventilator-associated pneumonia by bacteriologic analysis of bronchoscopic and nonbronchoscopic "blind" bronchoalveolar lavage fluid. Am Rev Respir Dis. 1991 May;143(5 Pt 1):1121-9. doi: 10.1164/ajrccm/143.5_Pt_1.1121. |
| 14566455 | Background | Schurink CAM, Nieuwenhoven CAV, Jacobs JA, Rozenberg-Arska M, Joore HCA, Buskens E, Hoepelman AIM, Bonten MJM. Clinical pulmonary infection score for ventilator-associated pneumonia: accuracy and inter-observer variability. Intensive Care Med. 2004 Feb;30(2):217-224. doi: 10.1007/s00134-003-2018-2. Epub 2003 Oct 18. |
| 15312219 | Background | Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24. |
| 26903338 | Background | Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. |
| Background | Stevens V, Yoo, M, Brown J. Cost and Length of Stay Associated with Vancomycin-Induced Nephrotoxicity. Value in Health , Volume 16 , Issue 7 , A349 |
| 19\. Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, n.d. Web. 26 Jan. 2017 | View source |