Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP (NIHCAP)

This study has been withdrawn prior to enrollment.
(Decision by NIH)
Sponsor:
Collaborators:
University of Louisville
Louisville VA Medical Center
Johns Hopkins University
Summa Health System
Baylor College of Medicine
Ben Taub Hospital
VA Medical Center, Houston
Beth Israel Medical Center
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01662258
First received: August 3, 2012
Last updated: April 18, 2016
Last verified: April 2016
  Purpose

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 Intervention
Community-acquired Pneumonia
Device: Point-of-Care diagnostic laboratory test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration [ Time Frame: 30 days after enrollment ] [ Designated as safety issue: No ]
    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:
  • Identification of microbial etiology by laboratory testing [ Time Frame: 30 days following enrollment, although microbial identification usually occurs within 5 days. ] [ Designated as safety issue: No ]
    POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.


Enrollment: 0
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • The POC tests are:
  • FilmArray (Idaho Tech, Salt Lake City, UT)
  • Xpert Flu (Cepheid, Sunnyvale, CA)
  • Vidas Brahms Procalcitonin (BioMerieux, Durham, NC)
  • Urinary antigen for Strep pneumoniae (Alere, Waltham, MA)
  • Legionella BinaxNOW urinary antigen(Alere, Waltham, MA)
  • Gram stain of respiratory secretions
No Intervention: Empiric therapy
Option of no application of POC laboratory tests

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662258

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, New York
Beth Israel
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
Sponsors and Collaborators
University of Pittsburgh
University of Louisville
Louisville VA Medical Center
Johns Hopkins University
Summa Health System
Baylor College of Medicine
Ben Taub Hospital
VA Medical Center, Houston
Beth Israel Medical Center
Investigators
Principal Investigator: Victor L Yu, M.D. University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01662258     History of Changes
Other Study ID Numbers: HHSN272201000040C 
Study First Received: August 3, 2012
Last Updated: April 18, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Community-acquired pneumonia
Targeted strategy
Empiric therapy

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 26, 2016