Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

University of Pittsburgh

Overview

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 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Community-acquired Pneumonia

Interventions

Point-of-Care diagnostic laboratory testDEVICE

All POC tests are FDA-cleared.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Louisville

Louisville, Kentucky, United States

Johns Hopkins

Baltimore, Maryland, United States

Beth Israel

New York, New York, United States

Summa Health System

Akron, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days after enrollment

Secondary Outcomes

Identification of microbial etiology by laboratory testing

POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.

Time frame: 30 days following enrollment, although microbial identification usually occurs within 5 days.

Data from ClinicalTrials.gov

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