NCT02420366

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 257 (actual)
• Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2015-04-17
• Last updated: 2018-05-02

Locations

22 sites across 4 countries: United States, Greece, Italy, United Kingdom