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Completed

NCT Number: NCT03586362

Vancomycin De-escalation Therapy in Patients With Pneumonia

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CAMC Health System

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2018
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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