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NCT02420366 Clinical Trial

Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02420366
Other study ID # Rempex 506 NH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2014
Est. completion date January 2015

Study information
Verified date April 2018
Source Melinta Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 257
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)

Countries where clinical trial is conducted

United States,  Greece,  Italy,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of positive CRE infections (specifically cUTI, AP, HABP, VABP, Bacteremia) in a target patient population 6 month period from September 1, 2013 to March 1, 2014
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