NCT00177957

Brief Summary

The aims of this study are to:

  • Determine the risk factors for multidrug resistance in bloodstream isolates of Gram negative bacilli
  • Determine the mechanisms of multidrug resistance in bloodstream isolates of Gram negative bacilli
  • Determine the risk factors for failure of prompt clearance of the blood of Gram negative bacteria
  • Determine the survival of patients with Gram negative bacteremia
  • Determine if failure of prompt clearance of the blood of Gram negative bacteria is a predictor of mortality following this infection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

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

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

11.1 years

First QC Date

September 13, 2005

Last Update Submit

June 8, 2017

Conditions

Gram-Negative Bacterial Infections

Keywords

Gram negative bacteremia

Outcome Measures

Primary Outcomes (1)

  • outcome of dead or alive post treatment

    dead or alive

    December 2020

Eligibility Criteria

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

patients with gram negative bacteremia

You may qualify if:

  • All patients at the aforementioned institutions that have Gram negative bacteremia will be included in the study.
  • Women with childbearing potential will also be included in this study. Since this is an observational study, no added risk is conferred to the woman or potential progeny. HIV serostatus will not be specifically investigated for participation in this study.

You may not qualify if:

  • None

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

Gram-Negative Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Yohei Doi, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

not sharing

Locations

US(1)