Swab Testing to Optimize Pneumonia Treatment With Empiric Vancomycin

NCT06272994 | Completed Results FDA Device

• 1 other identifier: 231724
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, pragmatic, randomized clinical trial (pRCT) examining whether reporting the results of a negative rapid PCR back to the provider via a pager alert results in decreased vancomycin utilization for critically ill adults with community-acquired pneumonia when compared with usual care.

Conditions

Community-acquired Pneumonia

Keywords

MRSA; Vancomycin; Nasal Swab

Outcome Measures

Primary Outcomes (1)

• Vancomycin-free Hours Alive

  The number of hours out of the seven days following enrollment in the trial that the patient is alive and not receiving vancomycin estimated using a proportional odds ratio model with the ordinal status levels being alive and not on vancomycin, alive and on vancomycin, or dead.

  Baseline to seven days following enrollment.

Secondary Outcomes (2)

• Time Alive Off Vancomycin

  Baseline to seven days following enrollment.

• 30-day All-cause Mortality

  Thirty days following enrollment.

Study Arms (2)

No MRSA Nasal Swab

NO INTERVENTION

Subjects will not have a nasal swab collected.

MRSA Nasal Swab

ACTIVE COMPARATOR

Subjects will have a nasal swab collected and sent to the clinical laboratory for the MRSA nasal swab PCR test to be run. For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.

Diagnostic Test: MRSA Nasal Swab PCR

Interventions

MRSA Nasal Swab PCR DIAGNOSTIC_TEST

For the subjects assigned to the intervention group who have a negative MRSA nasal swab PCR result, providers will receive a pager alert which inform them of the negative result and will direct clinicians to clinical guidance recommending clinicians to discontinue vancomycin, if clinically appropriate.

MRSA Nasal Swab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age greater than or equal to 18) patients admitted/transferred to the Vanderbilt University Medical Center (VUMC) Medical Intensive Care Unit (MICU) from the VUMC Emergency Department or from a hospital floor within 48 hours of admission.
• Suspicion for pneumonia on admission (defined as an indication for antibiotics of "respiratory infection" and/or an order for a respiratory culture i.e., sputum culture, tracheal aspirate culture, or bronchoalveolar lavage (BAL) culture).
• No topical nasal decolonization during hospitalization prior to collection of MRSA nasal swab PCR.
• Must match both of the following in either order:
• The patient has been admitted to and physically located in the MICU.
• The patient has received a continuing vancomycin order, or a pharmacokinetics consult for a continuing vancomycin order, no later than 24 hours following their physical admission to the MICU.

You may not qualify if:

• Hospital stay of longer than 48 hours prior to MICU admission.
• Known to be a prisoner

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Jeffrey A. Freiberg, MD, PhD
• Organization: Vanderbilt University Medical Center

jeffrey.freiberg@vumc.org

615-875-8663

Study Officials

• Jeffrey Freiberg, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Infectious Diseases, MD, PhD

Model Details: This study will be performed as a single center, pragmatic, randomized clinical trial.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: April 3, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 27, 2025
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (1)