Community-acquired Pneumonia
Conditions
Keywords
Community-acquired pneumonia, Targeted strategy, Empiric therapy
Brief summary
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
Detailed description
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
Interventions
DEVICEPoint-of-Care diagnostic laboratory test
All POC tests are FDA-cleared.
Sponsors
University of Louisville
Louisville VA Medical Center
Johns Hopkins University
Summa Health System
Baylor College of Medicine
Ben Taub Hospital
Michael E. DeBakey VA Medical Center
Beth Israel Medical Center
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration | 30 days after enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of microbial etiology by laboratory testing | 30 days following enrollment, although microbial identification usually occurs within 5 days. | POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum) | 30 days after enrollment although most patients will be evaluable within 5 days | 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. |
| Length of stay (LOS) for hospitalized patients | 30 days after enrollment | Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure. |
Countries
United States
Outcome results
None listed