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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 belowSelect...
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.
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.
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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
904 Previous Clinical Trials
933,819 Total Patients Enrolled
1 Trials studying Community-acquired Pneumonia
Jeffrey Freiberg, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center