NCT00366223

Brief Summary

The purpose of this study is to determine the changing patterns of infection caused by Candida species in urban medical centers and its influence on patient outcomes. A retrospective cohort study design will be employed with the main outcome measure being hospital mortality. Secondary outcomes including microbiologic clearance of the infection, duration of hospitalization, and the intensive care unit (ICU) length of stay will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

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

August 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
10.8 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

10.8 years

First QC Date

August 18, 2006

Last Update Submit

June 11, 2018

Conditions

Keywords

infectioncandida

Outcome Measures

Primary Outcomes (1)

  • dead or alive

    Health status

    end of study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

candida blood culture

You may qualify if:

  • All hospitalized patients with a positive blood culture for Candida will be eligible.

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.

MeSH Terms

Conditions

InfectionsTorulopsis

Study Officials

  • David L Paterson, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 21, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 12, 2018

Record last verified: 2018-06

Locations