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

Completed

• Conditions: Acute Pyelonephritis; Ventilator-associated Bacterial Pneumonia; Bacteremia; Urinary Tract Infection, Complicated; Hospital Acquired Bacterial Pneumonia

• Registration Number: NCT02420366
• Lead Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)

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.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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