Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP (NIHCAP)
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Purpose
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
| Condition | Intervention |
|---|---|
|
Community-acquired Pneumonia |
Device: Point-of-Care diagnostic laboratory test |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia |
- Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration [ Time Frame: 30 days after enrollment ] [ Designated as safety issue: No ]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
- Identification of microbial etiology by laboratory testing [ Time Frame: 30 days following enrollment, although microbial identification usually occurs within 5 days. ] [ Designated as safety issue: No ]POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.
- 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 ] [ Designated as safety issue: No ]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 [ Time Frame: 30 days after enrollment ] [ Designated as safety issue: No ]Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.
| Estimated Enrollment: | 5500 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Device: Point-of-Care diagnostic laboratory test
All POC tests are FDA-cleared.
Other Names:
|
|
No Intervention: Empiric therapy
Option of no application of POC laboratory tests
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Kentucky | |
| University of Louisville | Not yet recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Julio Ramirez, M.D. 502-852-7844 j.ramirez@louisville.edu | |
| Sub-Investigator: Julio Ramirez, M.D. | |
| United States, Maryland | |
| Johns Hopkins | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: John Bartlett, M.D. 410-955-5464 jb@jhmi.edu | |
| Sub-Investigator: John Bartlett, M.D. | |
| United States, New York | |
| Beth Israel | Not yet recruiting |
| New York, New York, United States, 10003 | |
| Contact: Donna Mildvan, M.D. 212-420-4005 dmildvan@chpnet.org | |
| Sub-Investigator: Donna Mildvan, M.D. | |
| United States, Ohio | |
| Summa Health System | Not yet recruiting |
| Akron, Ohio, United States, 44304 | |
| Contact: Thomas File, M.D. 330-375-3894 filet@summa-health.org | |
| Sub-Investigator: Thomas File, M.D. | |
| United States, Texas | |
| Baylor College of Medicine | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Daniel Musher, M.D. 713-791-1414 ext 5420 daniel.musher@va.gov | |
| Sub-Investigator: Daniel Musher, M.D. | |
| Principal Investigator: | Victor L Yu, M.D. | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Victor Yu, Professor of Medicine, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01662258 History of Changes |
| Other Study ID Numbers: | HHSN272201000040C |
| Study First Received: | August 3, 2012 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Community-acquired pneumonia Targeted strategy Empiric therapy |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013