Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP (NIHCAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01662258|
Recruitment Status : Withdrawn (Decision by NIH)
First Posted : August 10, 2012
Last Update Posted : April 19, 2016
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 or disease||Intervention/treatment||Phase|
|Community-acquired Pneumonia||Device: Point-of-Care diagnostic laboratory test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
No Intervention: Empiric therapy
Option of no application of POC laboratory tests
- Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration [ Time Frame: 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
- Identification of microbial etiology by laboratory testing [ Time Frame: 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.
- 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 ]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 ]Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662258
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|New York, New York, United States, 10003|
|United States, Ohio|
|Summa Health System|
|Akron, Ohio, United States, 44304|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Victor L Yu, M.D.||University of Pittsburgh|