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

April 30, 2018 updated by: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)

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

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)

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

257

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527 Goudi
  • Italy
      • Bologna, Italy, 40138
      • Firenze, Italy, 50134
      • Genova, Italy, 16132
      • Pisa, Italy, 56124
      • Roma, Italy, 168
      • Rome, Italy, 161
      • Udine, Italy, 33100
  • United Kingdom
      • Manchester, United Kingdom, MI39WL
      • Manchester, United Kingdom, M239LT
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Evanston, Illinois, United States, 60201
    • Michigan
      • Detroit, Michigan, United States, 48201
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
      • Somers Point, New Jersey, United States, 08244
    • New York
      • New York, New York, United States, 10032
      • New York, New York, United States, 10065
      • Rochester, New York, United States, 14642
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cleveland, Ohio, United States, 44195
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
    • Virginia
      • Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with serious CRE infections identified by chart review at up to 20 sites

Description

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:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (ESTIMATE)

April 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rempex 506 NH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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