NCT02420366

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
4 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

April 8, 2015

Last Update Submit

April 30, 2018

Conditions

Urinary Tract Infection, ComplicatedAcute PyelonephritisHospital Acquired Bacterial PneumoniaVentilator-associated Bacterial PneumoniaBacteremia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Evanston, Illinois, 60201, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08901, United States

Location

Unknown Facility

Somers Point, New Jersey, 08244, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Rochester, New York, 14642, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15261, United States

Location

Unknown Facility

Charlottesville, Virginia, 22908, United States

Location

Unknown Facility

Athens, 11527 Goudi, Greece

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Florence, 50134, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Pisa, 56124, Italy

Location

Unknown Facility

Roma, 168, Italy

Location

Unknown Facility

Rome, 161, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Manchester, M239LT, United Kingdom

Location

Unknown Facility

Manchester, MI39WL, United Kingdom

Location

MeSH Terms

Conditions

Urinary Tract InfectionsBacteremia

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBacterial InfectionsBacterial Infections and MycosesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karen Fusaro

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 17, 2015

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

GB(2)US(12)GR(1)IT(7)