Clinical trial NCT01662258: Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP
Official title: Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: Community-acquired pneumonia
Targeted strategy
Empiric therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Louisville
name: Louisville VA Medical Center
name: Johns Hopkins University
name: Summa Health System
name: Baylor College of Medicine
name: Ben Taub Hospital
name: Michael E. DeBakey VA Medical Center
name: Beth Israel Medical Center
First posted: 2012-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration
timeFrame: 30 days after enrollment
Secondary outcomes:
measure: Identification of microbial etiology by laboratory testing
timeFrame: 30 days following enrollment, although microbial identification usually occurs within 5 days.
Other outcomes:
measure: Receipt of narrow spectrum antimicrobial agent targeted toward a specific microbe (as opposed to empiric antimicrobial therapy that is broad-spectrum)
timeFrame: 30 days after enrollment although most patients will be evaluable within 5 days
measure: Length of stay (LOS) for hospitalized patients
timeFrame: 30 days after enrollment
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Beth Israel
state: New York
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Victor L Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: