Vancomycin De-escalation Therapy in Patients With Pneumonia

CAMC Health System

Status: Active, not recruiting

Conditions: Pneumonia

Study type: Observational

Funder types: Other

Identifiers

NCT03586362

17-406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

278 participants in 2 patient groups

Treatment Group A

Description:

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

Description:

Patients admitted for pneumonia whose empiric vancomycin is continued for ≥24 hours after electronic health record documentation of negative MRSA nasal swab results.