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)

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Key information

Conditions

Urinary Tract Infection, Complicated Acute Pyelonephritis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hospital Acquired Bacterial Pneumonia Infections Inflammation Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Urinary Tract Infections Urogenital Diseases Urologic Diseases Ventilator-associated Bacterial Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Athens, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 17, 2015
Registry last updated: May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed