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

Primary Purpose

Community-acquired Pneumonia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point-of-Care diagnostic laboratory test
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Community-acquired pneumonia, Targeted strategy, Empiric therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville
  • Johns Hopkins
  • Beth Israel
  • Summa Health System
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Point-of-Care diagnostic laboratory test

Empiric therapy

Arm Description

Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests.

Option of no application of POC laboratory tests

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Identification of microbial etiology by laboratory testing
POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.

Full Information

First Posted
August 3, 2012
Last Updated
April 18, 2016
Sponsor
University of Pittsburgh
Collaborators
University of Louisville, Louisville VA Medical Center, Johns Hopkins University, Summa Health System, Baylor College of Medicine, Ben Taub Hospital, Michael E. DeBakey VA Medical Center, Beth Israel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01662258
Brief Title
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP
Acronym
NIHCAP
Official Title
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Decision by NIH
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
University of Louisville, Louisville VA Medical Center, Johns Hopkins University, Summa Health System, Baylor College of Medicine, Ben Taub Hospital, Michael E. DeBakey VA Medical Center, Beth Israel Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Community-acquired pneumonia, Targeted strategy, Empiric therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Point-of-Care diagnostic laboratory test
Arm Type
Experimental
Arm Description
Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests.
Arm Title
Empiric therapy
Arm Type
No Intervention
Arm Description
Option of no application of POC laboratory tests
Intervention Type
Device
Intervention Name(s)
Point-of-Care diagnostic laboratory test
Other Intervention Name(s)
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
Intervention Description
All POC tests are FDA-cleared.
Primary Outcome Measure Information:
Title
Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration
Description
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
Time Frame
30 days after enrollment
Secondary Outcome Measure Information:
Title
Identification of microbial etiology by laboratory testing
Description
POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.
Time Frame
30 days following enrollment, although microbial identification usually occurs within 5 days.
Other Pre-specified Outcome Measures:
Title
Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)
Description
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.
Time Frame
30 days after enrollment although most patients will be evaluable within 5 days
Title
Length of stay (LOS) for hospitalized patients
Description
Educational measures using evidence-based endpoints for clinical response will lead to shorter LOS without concomitant increase in complications or clinical failure.
Time Frame
30 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor L Yu, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

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