Vancomycin De-escalation Therapy in Patients With Pneumonia

July 19, 2022 updated by: Rayan Ihle, CAMC Health System

Vancomycin De-escalation Therapy in Patients With Pneumonia and Negative MRSA Nasal Swab

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Evaluation will be completed 48 hours after 7 days of antibiotic therapy for pneumonia.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During patient hospital stay for up to 6 months
In-hospital mortality
Time Frame: During patient hospital stay for up to 6 months
Number of deaths
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 Frame: Time between vancomycin administration and discharge from hospital for up to 6 months.
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
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
During patient hospital stay for up tp 6 months
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
During patient hospital stay for up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAMC Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-406

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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