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Trial record 95 of 528 for:    VANCOMYCIN

Vancomycin De-escalation Therapy in Patients With Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03586362
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Information provided by (Responsible Party):
Audis Bethea, Pharm.D., CAMC Health System

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.

Condition or disease

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vancomycin De-escalation Therapy in Patients With Pneumonia and Negative MRSA Nasal Swab
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.

Primary Outcome Measures :
  1. Rate of Clinical Improvement [ Time Frame: Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia. ]

    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)

Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: During patient hospital stay for up to 6 months ]
    Date of admission to date of discharge from the hospital

  2. In-hospital mortality [ Time Frame: During patient hospital stay for up to 6 months ]
    Number of deaths

  3. 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 Frame: Time between vancomycin administration and discharge from hospital for up to 6 months. ]
    Number of kidney injuries following administration of vancomycin

  4. Hospital complications, such as MRSA bacteremia and septic shock [ Time Frame: During patient hospital stay for up tp 6 months ]
    Number of MRSA bacteremia and septic shock patients whose MRSA nasal swab is negative and have MRSA pneumonia

  5. Billing cost associated with vancomycin therapy and laboratory monitoring [ Time Frame: During patient hospital stay for up to 6 months ]
    Total charges associated with vancomycin therapy and laboratory monitoring

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03586362

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Contact: Audis Bethea, PharmD, BCPS 304-388-3653
Contact: Audis Bethea 304-388-3653

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United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Audis Bethea    304-388-3653   
Contact: Audis Bethea    3043883653   
Principal Investigator: Hesham Mohamed, MD         
Principal Investigator: Ryan Ihle, MD         
Principal Investigator: Mark Gustafson, DO         
Sub-Investigator: Damayanti Samanta, MS         
Sub-Investigator: Alfred Tager, MD         
Sub-Investigator: Suazanne Kemper, MS         
Sub-Investigator: Kristen Babiak, DO         
Sponsors and Collaborators
CAMC Health System
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Principal Investigator: Audis Bethea, PharmD, BCPS CAMC Health System

Additional Information:
Stevens V, Yoo, M, Brown J. Cost and Length of Stay Associated with Vancomycin-Induced Nephrotoxicity. Value in Health , Volume 16 , Issue 7 , A349

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Responsible Party: Audis Bethea, Pharm.D., Clinical Pharmacy Specialist, Clinical Research Scientist, CAMC Health System Identifier: NCT03586362     History of Changes
Other Study ID Numbers: 17-406
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Audis Bethea, Pharm.D., CAMC Health System:
MRSA nasal swab
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents