Candidemia Prognostic Factor and Mycobiological Analysis.NCT01211041
The Relationship Between Morphology and Virulent Genes of Candida Albicans and Clinical Aspects, Surveillance of Fungemia
An observational study of Candidemia Prognostic Factor and Mycobiological Analysis., run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Candida albicans is the most common and important clinical fungal pathogen. Our previous surveillance disclosed that fluconazole could induce different morphological changes in clinical strains. Our current study on C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia Prognostic Factor and Mycobiological Analysis.
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2010to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: case with candidemia of Candida albicans and candida caused the disease .
Who may be able to join
- 2007 to 2010 medical records
- Cases with candidemmia of Candida albicans with available clinical information in medical records for analysis.
- Cases with candidemmia of Candida albicans which clinical isolates were preserved.
Who cannot join
- Cases were not hospitalized for treatment and data were not available for analysis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University - WanFang Hospital
Taipei
Tsong-Yih Ou, 886-2-29307930 ext. 1760, 93023@wanfang.gov.tw
About this study
Candida albicans is the most common and important clinical fungal pathogen. Our previous surveillance disclosed that fluconazole could induce different morphological changes in clinical strains. Our current study on C. albicans causing candiuria disclosed that renal insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of treatment failure. However, we also found results of E-test drug susceptible test could not predict outcome. Hence, retrospective analysis of 31 months period, cases that had C. albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological study and potential virulent gene analysis.
This study is designed to clarity the clinical meaning of morphological form and virulent genes on candidemia. To do this study is probably helpful for treatment of candidiasis.
- Keywords
- Candida albicans, fungemia , prognostic factor
- Medical subject headings
- Fungemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJul 2010
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidemia Prognostic Factor and Mycobiological Analysis.Studies 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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tsong-Yih Ou, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211041
- Sponsor's protocol ID
- 99026
- Status last verified
- Apr 2011
- First submitted
- 28 Sep 2010
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Morphology and Virulent Genes of Candida Albicans and Clinical Aspects, Surveillance of Fungemia
- ClinicalTrials.gov ID
- NCT01211041
- Acronym / sponsor ID
- 99026
- Keywords
- Candida albicans, fungemia , prognostic factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Study completion
- Jul 2011 (estimated)
- First posted
- 29 Sep 2010 (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.
Candida albicans is the most common and important clinical fungal pathogen. Our previous surveillance disclosed that fluconazole could induce different morphological changes in clinical strains. Our current study on C. albicans causing candiuria disclosed that renal insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of treatment failure. However, we also found results of E-test drug susceptible test could not predict outcome. Hence, retrospective analysis of 31 months period, cases that had C. albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological study and potential virulent gene analysis.
This study is designed to clarity the clinical meaning of morphological form and virulent genes on candidemia. To do this study is probably helpful for treatment of candidiasis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- case with candidemia of Candida albicans and candida caused the disease .
Key inclusion criteria (3 listed)
- 2007 to 2010 medical records
- Cases with candidemmia of Candida albicans with available clinical information in medical records for analysis.
- Cases with candidemmia of Candida albicans which clinical isolates were preserved.
Key exclusion criteria (1 listed)
- Cases were not hospitalized for treatment and data were not available for analysis.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
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.
Tsong-Yih Ou principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia Prognostic Factor and Mycobiological Analysis., run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsong-Yih Ou (886-2-29307930 ext. 1760, 93023@wanfang.gov.tw), or a site near the patient. 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 25 Apr 2011.