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CompletedNCT03827330Updated Nov 27, 2020

Retrospective Chart Review of Candida Fungemia

An observational study in Candida Fungemia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2020-11-27.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
75
Ages
6 Years and older
Sex
All
01

Study summary

Background:

Candida can cause infections. The most common kind of Candida at clinics is C albicans. But other kinds have increased at clinics too. Researchers want to review the records of people who were in previous NIH studies who had Candida. They want to find out what risk factors are associaated with this infection.

Objective:

To study the factors that are associated with Candida fungemia to develop. The factors are clinical features, diagnoses, and previous antifungal therapy.

Eligibility:

People who were in prior NIH studies and had Candida

Design:

Researchers will review the records of 62 NIH participants. The records are from 2004 to 2017. They will look at data such as blood test results, diagnosis, and treatments.

Researchers will only reach out to participants if they get approval from a review board.

This research will probably not reveal data that would be important to participants health. But if it does, researchers will try to contact those participants.

Data will be stored in secure computers. They will be stored with a code that only the study team can link to a participant.

Read the detailed description

This protocol is a chart review of patients who had Candida species grown from blood cultures drawn at the National Institutes of Health. The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s). Principal investigators of each protocol have been contacted to request permission to conduct this study, and to verify that none of the original protocols or informed consent documents precludes such a review of clinical data.

02

Conditions studied

  • Candida Fungemia

Browse trials for

Keywords

  • Candida Parapsilosis
  • Candida Auris
  • Candida Lusitaniae
  • Candida Glabrata
  • Candida Albicans
03

In context

Fungemia

32 studies on the registry are indexed under Fungemia; 3 are open to participants now.

This study's enrollment of 75 is below the median of 740 across 12 observational studies indexed under Fungemia.

Browse Fungemia studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who had Candida species grown from blood cultures drawn at the National Institutes of Health from 2004 until 2017.

Eligibility criteria

  • The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
75 participants (actual)

Groups and cohorts

  • Patients

    Patients who had Candida species growth from blood cultures drawn at the National Institutes of Health

06

What researchers measure

Primary outcomes

  1. The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of n...

    The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of non-albicans species of Candida.

    Time frame: Duration of study

07

Study locations

1 site
  • National Institute of Allergy and Infectious Diseases (NIAID)
    Bethesda, Maryland 20892, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Nov 2020, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2019
First posted
Feb 1, 2019
StartActual
Jan 3, 2019
Primary completionActual
Nov 18, 2020
CompletionActual
Nov 18, 2020
Last update
Nov 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03827330
Responsible party
Sponsor
First posted
Feb 1, 2019
Start date
Jan 3, 2019
Primary completion
Nov 18, 2020
Completion
Nov 18, 2020
Last update
Nov 27, 2020

Study contacts

Michail S Lionakis, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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