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

University of Pittsburgh

Status: Withdrawn

Conditions: Community-acquired Pneumonia

Treatments: Device: Point-of-Care diagnostic laboratory test

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01662258

HHSN272201000040C

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Point-of-Care diagnostic laboratory test

Experimental group

Description:

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

Treatment:

Device: Point-of-Care diagnostic laboratory test

Empiric therapy

No Intervention group

Description:

Option of no application of POC laboratory tests