Multi-center, Retrospective Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)0 sites257 target enrollmentMay 2014

ConditionsUrinary Tract Infection, Complicated Acute Pyelonephritis Hospital Acquired Bacterial Pneumonia Ventilator-associated Bacterial Pneumonia Bacteremia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urinary Tract Infection, Complicated
Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Enrollment: 257
Primary Endpoint: Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

January 2015

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female ≥18 years of age.
•Carbapenem resistant Enterobacteriaceae (CRE) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cUTI or AP, HABP, VABP, and/or bacteremia.
•Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia.