Vancomycin De-escalation Therapy in Patients With Pneumonia

NCT03586362 | Unknown

• 1 other identifier: 17-406
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia

Keywords

Vancomycin; MRSA nasal swab; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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. * Afebrile: Temperature \<38.0ºC or \<100.4ºF * Improvement of respiratory symptoms and signs per clinical documentation: cough, dyspnea, tachypnea, purulent sputum, increase respiratory secretions, increased suctioning requirements * White blood count (WBC) trending down by at least 25%, or when baseline was≤ 15,000 mm3, or return to the normal values * Less oxygen supplementation and ventilation * Chest radiographic improvement per radiologist report (e.g. infiltrate, consolidation or cavitation)

  Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia.

Secondary Outcomes (5)

• Hospital Length of Stay

  During patient hospital stay for up to 6 months

• In-hospital mortality

  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.

  Time between vancomycin administration and discharge from hospital for up to 6 months.

• Hospital complications, such as MRSA bacteremia and septic shock

  During patient hospital stay for up tp 6 months

• Billing cost associated with vancomycin therapy and laboratory monitoring

  During patient hospital stay for up to 6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to Charleston Area Medical Center through the Emergency Department with a diagnosis of pneumonia will be evaluated for potential enrollment.

You may qualify if:

• Age \>= 18 years old
• Patients admitted to Charleston Area Medical Center (CAMC) through the Emergency Department who meet the CDC criteria for pneumonia.
• Nasal surveillance culture for MRSA obtained in the Emergency Department
• Patients receiving vancomycin and additional antibiotic therapy for gram-negative coverage

You may not qualify if:

• Persistent vasopressor requirements when MRSA nasal swab results are available
• Patients not meeting the CDC criteria for pneumonia
• Patients presenting to the ED with leukopenia (≤4000) without previous documentation of normal or elevated WBC
• Patients receiving empiric MRSA antibiotic therapy other than vancomycin for pneumonia
• Patients with the diagnosis of lung abscess
• Patients not receiving vancomycin therapy before MRSA nasal swab results are reported
• Immunocompromised individuals. i.e. patients with AIDS/HIV, vasculitis on immune suppressor therapy, steroid therapy for more than one week prior admission or who received chemotherapy in the last 3 months
• Patients who do not have a MRSA nasal swab obtained in the ED
• Nares swab obtained after the completion of the first administered dose of an antibiotic with activity against MRSA
• Patients with MRSA bacteremia
• Patients with chronic tracheostomy

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Related Publications (23)

• 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.

  PMID: 18992647 BACKGROUND

• 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.

  PMID: 9397368 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.

  PMID: 9613899 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.

  PMID: 7634921 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.

  PMID: 23999949 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.

  PMID: 18462093 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.

  PMID: 21208910 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.

  PMID: 27925784 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.

  PMID: 23165462 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.

  PMID: 19596879 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.

  PMID: 19106348 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.

  PMID: 21576448 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.

  PMID: 20103028 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.

  PMID: 9249217 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.

  PMID: 20962147 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.

  PMID: 21976769 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.

  PMID: 25554549 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.

  PMID: 25991589 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.

  PMID: 2024824 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.

  PMID: 14566455 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.

  PMID: 15312219 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.

  PMID: 26903338 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

  BACKGROUND

Related Links

• Pneumonia." Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 06 Oct. 2016. Web. 18 Jan. 2017
• 19\. Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, n.d. Web. 26 Jan. 2017

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Audis Bethea, PharmD, BCPS

  CAMC Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 13, 2018
• Study Start: February 8, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

US (1)