- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01662258
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP (NIHCAP)
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia
This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP).
Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to Empiric therapy in patients with viral pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins
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New York
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New York, New York, United States, 10003
- Beth Israel
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Ohio
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Akron, Ohio, United States, 44304
- SUMMA Health System
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
● Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU).
The definition of CAP is as follows:
- Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician - but has to be confirmed by board certified radiologist for inclusion in the study).
- At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL.
- Able to provide informed consent
- Read, signed, and dated informed consent document
- Available for follow-up for the planned duration of the study
Exclusion Criteria:
- Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents.
- Patients residing in long-term care facilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Point-of-Care diagnostic laboratory test
Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests.
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All POC tests are FDA-cleared.
Other Names:
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No Intervention: Empiric therapy
Option of no application of POC laboratory tests
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration
Time Frame: 30 days after enrollment
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Symptoms of sputum, cough, shortness of breath.
Objective signs of deterioration: Acute Respiratory Distress Syndrome, empyema,nonpulmonary infection by infecting microbe, ICU admission, rehospitalization within 7 days following discharge
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30 days after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of microbial etiology by laboratory testing
Time Frame: 30 days following enrollment, although microbial identification usually occurs within 5 days.
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POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.
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30 days following enrollment, although microbial identification usually occurs within 5 days.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)
Time Frame: 30 days after enrollment although most patients will be evaluable within 5 days
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Antiviral agents will be administered at POC (point-of-care) if Influenza virus is identified by molecular testing.
Penicillin compounds will be administered if Strep pneumoniae is identified.
Macrolides/quinolone will be administered if Mycoplasma pneumoniae and Legionella are identified.
Etc.
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30 days after enrollment although most patients will be evaluable within 5 days
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Length of stay (LOS) for hospitalized patients
Time Frame: 30 days after enrollment
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Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.
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30 days after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Victor L Yu, M.D., University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HHSN272201000040C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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