Urinary Tract InfectionsFACESNCT00787085
The Significance of Funguria in Hospitalized Patients
An observational study of Urinary Tract Infections, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.
Trial summary
This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 919 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2001to Feb 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center
Who may be able to join
- Patients hospitalized at least 12 hours of any age (< 1 day to > 100 years of age) AND a urine or blood culture positive for fungi, OR urine culture negative for fungi (control group)
Who cannot join
- Patients already surveyed for funguria during current hospitalization and patients already being followed for recognized funguria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: The Significance of Funguria in Hospitalized Patients (FACES)
This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine).
Read the detailed description
A recent large multi-center national surveillance survey of almost 5000 nosocomial (hospital based) urine isolates from medical intensive care units demonstrated that fungi comprised nearly 40% of urine isolates. Little is known about distinguishing fungi that cause colonization from those causing infection.
The objective of this study is to define the epidemiology of nosocomial funguria and natural history of patients that develop funguria while hospitalized.
Patients who may have eligible for this study will be identified from microbiology laboratory specimens at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center.
- Conditions
- Urinary Tract Infections
- Keywords
- Funguria, Epidemiology, Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients hospitalized with a urine or blood culture positive for fungi | |
| Control | Patients hospitalized with a urine culture negative for fungi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Funguria
Measured: Hospitalization day 0, 3, 7, 14, and every 7 days thereafter until hospital discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startSep 2001
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Cedars-Sinai Medical Center
- Investigators
- Loren G Miller, M.D., M.P.H., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787085
- Sponsor's protocol ID
- 10024-05
- Other IDs
- NIH-AI01831
- Acronym
- FACES
- Status last verified
- Nov 2008
- First submitted
- 6 Nov 2008
- Last updated
- 7 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Funguria in Hospitalized Patients (FACES)
- ClinicalTrials.gov ID
- NCT00787085
- Acronym / sponsor ID
- FACES / 10024-05
- Conditions
- Urinary Tract Infections
- Keywords
- Funguria, Epidemiology, Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Cedars-Sinai Medical Center
- Study start
- Sep 2001
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 7 Nov 2008 (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.
This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine).
Detailed description
A recent large multi-center national surveillance survey of almost 5000 nosocomial (hospital based) urine isolates from medical intensive care units demonstrated that fungi comprised nearly 40% of urine isolates. Little is known about distinguishing fungi that cause colonization from those causing infection.
The objective of this study is to define the epidemiology of nosocomial funguria and natural history of patients that develop funguria while hospitalized.
Patients who may have eligible for this study will be identified from microbiology laboratory specimens at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Patients hospitalized with a urine or blood culture positive for fungi |
| Control | – | –Patients hospitalized with a urine culture negative for fungi |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center
Key inclusion criteria (1 listed)
- Patients hospitalized at least 12 hours of any age (< 1 day to > 100 years of age) AND a urine or blood culture positive for fungi, OR urine culture negative for fungi (control group)
Key exclusion criteria (1 listed)
- Patients already surveyed for funguria during current hospitalization and patients already being followed for recognized funguria
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
Funguria
Time frame: Hospitalization day 0, 3, 7, 14, and every 7 days thereafter until hospital discharge or death
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 7 Nov 2008.
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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.
Loren G Miller, M.D., M.P.H. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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 Urinary Tract Infections, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 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 1 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 7 Nov 2008. 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.
What does the primary outcome measure?
Funguria (time frame: Hospitalization day 0, 3, 7, 14, and every 7 days thereafter until hospital discharge or death). It is what the study was designed to measure, not a finding.
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 7 Nov 2008.