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

Rempex Pharmaceuticals

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02420366

Rempex 506 NH

Details and patient eligibility

About

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)

Full 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.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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