Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP (NIHCAP)
|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Recruitment Status : Withdrawn (Decision by NIH)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.
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|