NCT01662258

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

August 3, 2012

Last Update Submit

April 18, 2016

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumoniaTargeted strategyEmpiric therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Identification of microbial etiology by laboratory testing

    30 days following enrollment, although microbial identification usually occurs within 5 days.

Other Outcomes (2)

  • Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)

    30 days after enrollment although most patients will be evaluable within 5 days

  • Length of stay (LOS) for hospitalized patients

    30 days after enrollment

Study Arms (2)

Point-of-Care diagnostic laboratory test

EXPERIMENTAL

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

Empiric therapy

NO INTERVENTION

Option of no application of POC laboratory tests

Interventions

Point-of-Care diagnostic laboratory testDEVICE

All POC tests are FDA-cleared.

Also known as: 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
Point-of-Care diagnostic laboratory test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Beth Israel

New York, New York, 10003, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Victor L Yu, M.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2012

First Posted

August 10, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

US(5)