Swab Testing for Community-Acquired Pneumonia

(STOP-Vanc Trial)

JF
GN
Overseen ByGeorge Nelson, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Must be taking: Vancomycin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a quick nasal swab test for MRSA (a type of bacteria) can reduce vancomycin use in adults with community-acquired pneumonia in the ICU. The trial will assess whether promptly notifying doctors of a negative MRSA result influences their decision to discontinue vancomycin. Participants should be adults with suspected pneumonia who have been admitted to the ICU and are currently receiving vancomycin. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance antibiotic use in critical care settings.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, it focuses on patients already receiving vancomycin, so you may need to continue that medication if you are already on it.

What prior data suggests that the MRSA Nasal Swab PCR is safe?

Research has shown that the MRSA nasal swab PCR test is a safe and effective method for detecting MRSA infections. Studies indicate it is over 95% accurate in confirming the absence of an MRSA infection, aiding doctors in deciding whether to safely discontinue antibiotics like vancomycin.

No reports of harmful effects from the nasal swab test have emerged. The swab involves a quick and simple procedure that collects a sample from inside the nose. It is non-invasive and causes little to no discomfort for most people. Therefore, for those considering participation in a trial that includes this test, current studies suggest it is well-tolerated and safe.12345

Why are researchers excited about this trial?

Researchers are excited about the MRSA Nasal Swab PCR test for community-acquired pneumonia because it offers a quick and non-invasive way to identify the presence of MRSA bacteria. Unlike traditional methods that require more time to culture bacteria, this nasal swab uses PCR technology to quickly detect MRSA, allowing for faster clinical decisions. If the test shows a negative result, it enables healthcare providers to discontinue the use of vancomycin, a strong antibiotic, which can reduce unnecessary antibiotic use and its associated side effects. This approach not only speeds up treatment decisions but also helps in combating antibiotic resistance.

What evidence suggests that the MRSA Nasal Swab PCR is effective for reducing vancomycin use in community-acquired pneumonia?

Research has shown that the MRSA Nasal Swab PCR test, which participants in this trial may receive, accurately rules out MRSA infections. It has a negative predictive value of over 95%, effectively confirming when someone does not have MRSA. In some studies, this accuracy reached 99.2%. This reliability helps determine when it's safe to stop using antibiotics like vancomycin, aiding doctors in avoiding unnecessary treatments and benefiting patient health.13467

Who Is on the Research Team?

JF

Jeffrey Freiberg, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with suspected pneumonia, admitted to Vanderbilt University Medical Center's MICU from the ER or hospital floor within 48 hours. They must be in the MICU and on vancomycin without prior nasal decolonization. Prisoners or those hospitalized for over 48 hours before MICU admission are excluded.

Inclusion Criteria

I am an adult admitted to the MICU from the ER or hospital floor within 48 hours.
I was suspected of having pneumonia when I was admitted.
I haven't had any nasal treatments to remove bacteria during my hospital stay before a nasal swab test.
See 1 more

Exclusion Criteria

Known to be a prisoner
I was in the hospital for more than 2 days before going to the MICU.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either MRSA nasal swab testing with potential vancomycin de-escalation or no swab testing

1 week
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 30-day all-cause mortality

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • MRSA Nasal Swab PCR
Trial Overview The study tests if a rapid PCR swab alerting doctors of negative MRSA results can reduce vancomycin use in critically ill adults with community-acquired pneumonia, compared to standard care without such alerts.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: MRSA Nasal SwabActive Control1 Intervention
Group II: No MRSA Nasal SwabActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

Predictive Value of Methicillin-Resistant Staphylococcus ...In our cohort, the overall NPV of the MRSA nasal swab PCR for MRSA infection was excellent at 99.2%, while the PPV was 35.5% when the test was used in the ...
Rapid and actionable nasal-swab screening supports ...Previous studies showed that MRSA nasal screening assays demonstrate exceptional negative predictive efficacy exceeding 95% (NPV > 95%) in ...
Clinical Utility of Methicillin-Resistant Staphylococcus aureus ...Outcomes evaluated for the clinical utility of MRSA nasal screening for predicting MRSA pneumonia included the performance characteristics of sensitivity, ...
Correlation of MRSA polymerase chain reaction (PCR) ...found a MRSA PCR nasal swab pooled sensitivity of 70.9%, specificity of 90.3%, positive predictive value (PPV) of 44.8 %, and NPV of 96.5 % for community- ...
Evaluation of Anti-Methicillin-Resistant Staphylococcus ...The MRSA nasal PCR has a high negative predictive value (NPV) of 94.8–99.2% for MRSA pneumonia [3,4,5,6,7]. Studies have demonstrated a ...
Impact of Methicillin-Resistant Staphylococcus aureus ...To optimize patient outcome and stewardship efforts, the community-acquired PNA (CAP) guideline recommend using MRSA testing via nasal swabs and ...
American Journal of Respiratory and Critical Care MedicineThis document provides evidence-based clinical practice guidelines on the management of adult patients with community-acquired pneumonia.
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