Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP
| Status: | Withdrawn |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | August 2013 |
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
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
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
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
We found this trial at
5
sites
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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University of Louisville The University of Louisville is a state supported research university located in...
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