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Decision by NIH
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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Louisville VA Medical Center | FED |
| Johns Hopkins University | OTHER |
| Summa Health System |
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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
The study will be conducted at five academic medical university sites with 7 hospitals. Empiric therapy is defined as selection of antibiotic therapy based on the 2007 ATS-IDSA guidelines in which broad-spectrum antibiotics are recommended, and microbial cause is uncertain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Point-of-Care diagnostic laboratory test | Experimental | Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests. |
|
| Empiric therapy | No Intervention | Option of no application of POC laboratory tests |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care diagnostic laboratory test | Device | All POC tests are FDA-cleared. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration | 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 | 30 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of microbial etiology by laboratory testing | POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes. | 30 days following enrollment, although microbial identification usually occurs within 5 days. |
| 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) | 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. |
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor L Yu, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville | Louisville | Kentucky | 40202 | United States | ||
| Johns Hopkins |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| OTHER |
| Baylor College of Medicine | OTHER |
| Ben Taub Hospital | OTHER |
| Michael E. DeBakey VA Medical Center | FED |
| Beth Israel Medical Center | OTHER |
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| 30 days after enrollment although most patients will be evaluable within 5 days |
| Length of stay (LOS) for hospitalized patients | Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure. | 30 days after enrollment |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Beth Israel | New York | New York | 10003 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| D012140 |
| Respiratory Tract Diseases |