CandidiasisNCT00138502
Funguria in Hospitalized Patients
An observational study of Candidiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
The purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy. Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Candidiasis
- How many people
- 926 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Sep 2001to 8 Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with fungi isolated from the urine of any colony count.
- Patients seen at either Harbor-UCLA Medical Center or Cedars Sinai Medical Center.
Who cannot join
- 1. Persons with a previously positive urine fungal culture during the current hospital admission.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cedars Sinai Medical Center
Los Angeles, California, 90048
UCLA Center For Vaccine Research
Torrance, California, 90509
About this study
Official title: The Significance of Funguria In Hospitalized Patients
The purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy.
Read the detailed description
This protocol will attempt to generate a detailed clinical profile of patients with funguria and identify subgroups of patients with funguria at high risk for candiduria and determine the relative risks for obtaining candiduria. In addition, it will look at identifying subgroups of patients with funguria at high risk for candidemia and identifying subgroups of patients with funguria at high risk for death. Finally, it will attempt to determine if funguria independently predicts fungemia or death. Data will be complemented by surveillance of a comparable population without funguria.
- Conditions
- Candidiasis
- Keywords
- Candidiasis, Funguria
- Medical subject headings
- Candidiasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study start17 Sep 2001
- Primary completion8 Dec 2008
- Study completion8 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 926 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138502
- Sponsor's protocol ID
- 02-050
- Status last verified
- Oct 2007
- First submitted
- 26 Aug 2005
- Last updated
- 4 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Funguria In Hospitalized Patients
- ClinicalTrials.gov ID
- NCT00138502
- Acronym / sponsor ID
- 02-050
- Conditions
- Candidiasis
- Keywords
- Candidiasis, Funguria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 926 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 17 Sep 2001
- Primary completion
- 8 Dec 2008 (actual)
- Study completion
- 8 Dec 2008 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test the hypothesis that a subpopulation of patients with candiduria are at significant risk for disseminated disease and would benefit from treatment, while others are at low risk from complications and therefore require no antifungal therapy.
Detailed description
This protocol will attempt to generate a detailed clinical profile of patients with funguria and identify subgroups of patients with funguria at high risk for candiduria and determine the relative risks for obtaining candiduria. In addition, it will look at identifying subgroups of patients with funguria at high risk for candidemia and identifying subgroups of patients with funguria at high risk for death. Finally, it will attempt to determine if funguria independently predicts fungemia or death. Data will be complemented by surveillance of a comparable population without funguria.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with fungi isolated from the urine of any colony count.
- Patients seen at either Harbor-UCLA Medical Center or Cedars Sinai Medical Center.
Key exclusion criteria (1 listed)
- 1. Persons with a previously positive urine fungal culture during the current hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.