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Vancomycin De-escalation Therapy in Patients With Pneumonia

Sponsor
CAMC Health System (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03586362
Collaborator
(none)
278
Enrollment
1
Location
70.7
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Feb 8, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Clinical Improvement [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 [During patient hospital stay for up to 6 months]

      Date of admission to date of discharge from the hospital

    2. In-hospital mortality [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 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 [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 [During patient hospital stay for up to 6 months]

      Total charges associated with vancomycin therapy and laboratory monitoring

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charleston Area Medical Center Charleston West Virginia United States 25304

    Sponsors and Collaborators

    • CAMC Health System

    Investigators

    • Principal Investigator: Audis Bethea, PharmD, BCPS, CAMC Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Rayan Ihle, M.D, CAMC Health System
    ClinicalTrials.gov Identifier:
    NCT03586362
    Other Study ID Numbers:
    • 17-406
    First Posted:
    Jul 13, 2018
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    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 Rayan Ihle, M.D, CAMC Health System
    Vancomycin
    MRSA nasal swab
    Pneumonia
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Jul 20, 2022