Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP
- Conditions
- Community-acquired Pneumonia
- Interventions
- Device: Point-of-Care diagnostic laboratory test
- Registration Number
- NCT01662258
- Lead Sponsor
- University of Pittsburgh
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
● 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Point-of-Care diagnostic laboratory test 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.
- Primary Outcome Measures
Name Time Method Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration 30 days after enrollment 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
- Secondary Outcome Measures
Name Time Method Identification of microbial etiology by laboratory testing 30 days following enrollment, although microbial identification usually occurs within 5 days. POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.
Trial Locations
- Locations (5)
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Beth Israel
🇺🇸New York, New York, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States