NCT00449735

Brief Summary

This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of E. coli. Additionally, the adequacy of empiric antibiotic therapy for E. coli bloodstream infections will be assessed. Finally, outcome will be recorded - this is all-cause mortality at 28 days from the time of the first positive blood culture. Hypothesis: Ciprofloxacin resistant strains are associated with admission from nursing home and with prior quinolone use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 12, 2018

Status Verified

June 1, 2018

Enrollment Period

10.3 years

First QC Date

March 19, 2007

Last Update Submit

June 11, 2018

Conditions

Bacterial Infections

Keywords

positive isolatesecoliblood culturespositive cultures for ecoliblood stream infections

Outcome Measures

Primary Outcomes (1)

  • dead or alive

    health status

    end of study

Eligibility Criteria

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

E coli positive cultures

You may qualify if:

  • Clinical information is collected by chart review of "case" and "control" patients.
  • A "case A" patient is defined as follows:
  • One or more blood cultures are positive for E. coli. The organism is ciprofloxacin resistant.
  • A "case B" patient is defined as follows:
  • One or more blood cultures are positive for E. coli. The organism is ciprofloxacin susceptible. Additionally, 4 controls who are in hospital at the same time as cases will be selected for each case.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • David L Paterson, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations

US(1)