Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

Study Overview
=================
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

Official Title
-----------------
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Device: Point-of-Care diagnostic laboratory test


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-Care diagnostic laboratory test<br>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<br>* All POC tests are FDA-cleared.<br>* Other names: Gram stain of respiratory secretions;|
| No Intervention: Empiric therapy<br>Option of no application of POC laboratory tests | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community-acquired pneumonia, Targeted strategy, Empiric therapy