What is the mechanism of action of this treatment?

The most common treatments for Community-acquired Pneumonia (CAP) are antibiotics, which target the bacterial pathogens responsible for the infection. Beta-lactam antibiotics, such as amoxicillin, work by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. Macrolides, like azithromycin, inhibit protein synthesis by binding to the bacterial ribosome, preventing the production of essential proteins. Fluoroquinolones, such as levofloxacin, interfere with bacterial DNA replication by inhibiting DNA gyrase and topoisomerase IV. Vancomycin, often used for severe cases or when methicillin-resistant Staphylococcus aureus (MRSA) is suspected, also inhibits cell wall synthesis but through a different mechanism than beta-lactams. These mechanisms are crucial for effectively eliminating the infection, reducing symptoms, and preventing complications. The timely and appropriate use of these antibiotics, as studied in trials like the one involving rapid PCR results, is essential to optimize treatment outcomes and minimize antibiotic resistance.

What side effects are associated with this type of intervention?

Common treatments for community-acquired pneumonia include beta-lactam antibiotics, macrolides, and fluoroquinolones. Beta-lactam antibiotics like ceftriaxone can cause allergic reactions, gastrointestinal upset, and, rarely, Clostridioides difficile infection. Macrolides such as azithromycin may lead to gastrointestinal disturbances, QT interval prolongation, and potential cardiac events. Fluoroquinolones like levofloxacin are associated with gastrointestinal issues, tendonitis, tendon rupture, and QT interval prolongation. Vancomycin, often used in severe cases, can cause nephrotoxicity, ototoxicity, and infusion-related reactions such as 'red man syndrome.'

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of community-acquired pneumonia (CAP), including broad-spectrum agents like vancomycin, which is often used empirically in severe cases. Other FDA-approved antibiotics for CAP include beta-lactam/beta-lactamase inhibitors (e.g., piperacillin-tazobactam), third- and fourth-generation cephalosporins (e.g., ceftriaxone, cefepime), and macrolides (e.g., azithromycin). These treatments are aimed at covering a wide range of potential bacterial pathogens, ensuring effective management of CAP in critically ill patients.

What other types of research exist?

Promising alternatives for 2024 include: 1) AI-driven clinical decision support systems that analyze patient data in real-time to recommend appropriate antibiotic use, 2) Enhanced rapid diagnostic tests such as CRISPR-based assays for quicker and more accurate pathogen identification, and 3) Mobile health applications that provide instant notifications and detailed reports to healthcare providers, ensuring timely and informed decision-making.

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Swab Testing for Community-Acquired Pneumonia (STOP-Vanc Trial)

N/A

Waitlist Available

Led By Jeffrey Freiberg, MD, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must match both of the following in either order: 1) The patient has been admitted to and physically located in the MICU. 2) 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.

Must not have

Hospital stay of longer than 48 hours prior to MICU admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thirty days following enrollment.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if quickly informing doctors that a patient does not have MRSA can reduce the use of a strong antibiotic called vancomycin in critically ill adults with pneumonia. The goal is to avoid unnecessary antibiotic use and its serious side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

This trial primarily involves diagnostic testing rather than medication; therefore, side effects may include discomfort or minor bleeding from the nasal swab procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was suspected of having pneumonia when I was admitted.

Select...

I was admitted to the MICU and received a vancomycin order within 24 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was in the hospital for more than 2 days before going to the MICU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to seven days following enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to seven days following enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to seven days following enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vancomycin-free hours alive

Secondary study objectives

30-day all-cause mortality

Time Alive off Vancomycin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: MRSA Nasal SwabActive Control1 Intervention

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.

Group II: No MRSA Nasal SwabActive Control1 Intervention

Subjects will not have a nasal swab collected.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Community-acquired Pneumonia (CAP) are antibiotics, which target the bacterial pathogens responsible for the infection. Beta-lactam antibiotics, such as amoxicillin, work by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. Macrolides, like azithromycin, inhibit protein synthesis by binding to the bacterial ribosome, preventing the production of essential proteins. Fluoroquinolones, such as levofloxacin, interfere with bacterial DNA replication by inhibiting DNA gyrase and topoisomerase IV. Vancomycin, often used for severe cases or when methicillin-resistant Staphylococcus aureus (MRSA) is suspected, also inhibits cell wall synthesis but through a different mechanism than beta-lactams. These mechanisms are crucial for effectively eliminating the infection, reducing symptoms, and preventing complications. The timely and appropriate use of these antibiotics, as studied in trials like the one involving rapid PCR results, is essential to optimize treatment outcomes and minimize antibiotic resistance.