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

Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia

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

Study Overview

• Status: Withdrawn
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Device: Point-of-Care diagnostic laboratory test

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • New York
    • New York, New York, United States, 10003
      • Beth Israel
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of microbial etiology by laboratory testing	POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.	30 days following enrollment, although microbial identification usually occurs within 5 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)	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.	30 days after enrollment although most patients will be evaluable within 5 days
Length of stay (LOS) for hospitalized patients	Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.	30 days after enrollment

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Johns Hopkins University; Baylor College of Medicine; Beth Israel Medical Center; University of Louisville; Michael E. DeBakey VA Medical Center; Summa Health System; Louisville VA Medical Center; Ben Taub Hospital
• Investigators: Principal Investigator: Victor L Yu, M.D., University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Community-acquired pneumonia; Empiric therapy; Targeted strategy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: HHSN272201000040C