Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Point-of-Care diagnostic laboratory test

Intervention Type DEVICE

All POC tests are FDA-cleared.

Empiric therapy

Option of no application of POC laboratory tests

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Point-of-Care diagnostic laboratory test

All POC tests are FDA-cleared.

Intervention Type DEVICE

Other Intervention Names

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The POC tests are: FilmArray (Idaho Tech, Salt Lake City, UT) Xpert Flu (Cepheid, Sunnyvale, CA) Vidas Brahms Procalcitonin (BioMerieux, Durham, NC) Urinary antigen for Strep pneumoniae (Alere, Waltham, MA) Legionella BinaxNOW urinary antigen(Alere, Waltham, MA) Gram stain of respiratory secretions

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No