Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 8:19 PM
Study NCT ID:
NCT01662258
Status:
WITHDRAWN
Last Update Posted:
2016-04-19
First Post:
2012-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision by NIH
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIHCAP
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: