Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-26 @ 1:19 AM
Study NCT ID:
NCT02420366
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Sponsor:
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Organization:
Study Overview
Official Title:
Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired Bacterial Pneumonia (VABP), and/or bacteremia caused by Carbapenem-Resistant Enterobacteriaceae (CRE)
Detailed Description:
This multi-center, retrospective study of cases of serious bacterial infections (including cUTI or AP, HABP, VABP, and/or bacteremia caused by CRE) will consist of a chart review over a 6 month period from September 1, 2013 to March 1, 2014. De-identified data will be collected from the chart review of at least 150 cases of selected infections due to CRE at approximately 20 sites.
The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.
Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.
The study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. There will be no patient identifying data collected as part of this study.
Charts of patients who meet study-defined criteria for cUTI or AP, HABP, VABP, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a Carbapenem-Resistant Enterobacteriaceae will be reviewed.
Study Oversight
Has Oversight DMC:
False
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?: