Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP

Community-acquired Pneumonia Clinical Trial

— NIHCAP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01662258
• Other study ID #: HHSN272201000040C
• Status: Withdrawn
• Phase: N/A
• First received: August 3, 2012
• Last updated: April 18, 2016
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: April 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Device:
• Point-of-Care diagnostic laboratory test
All POC tests are FDA-cleared.

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio
United States	Johns Hopkins	Baltimore	Maryland
United States	Baylor College of Medicine	Houston	Texas
United States	University of Louisville	Louisville	Kentucky
United States	Beth Israel	New York	New York

Sponsors (9)

Lead Sponsor	Collaborator
University of Pittsburgh	Baylor College of Medicine, Ben Taub Hospital, Beth Israel Medical Center, Johns Hopkins University, Louisville VA Medical Center, Summa Health System, University of Louisville, VA Medical Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	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.	No