CandiduriaNCT03910764
Surveillance Study of Candiduria in Hospitalized Patients
An observational study of Candiduria, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The purpose of the study is to explore the epidemiology, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis of patients with Candiduria. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candiduria
- How many people
- 536 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 16 Sep 2020
- 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: all patients with Candiduria
Who may be able to join
- patients with Candiduria
Who cannot join
- patients without Candiduria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Surveillance Study of Candiduria in Hospitalized Patients
The purpose of the study is to explore the epidemiology, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis of patients with Candiduria.
Read the detailed description
The study is a retrospective study. Investigators will review medical records of patients with Candiduria from January 2015 to December 2017 to collect data about personal data, underlying diseases, indwelling catheter duration, laboratory data of urine routines and urine cultures, the symptom of fever, diagnosis, treatment and prognosis. After the data collection, investigators will run a descriptive statistics to find out the profile of the medical care of Candiduria in Taiwan.
- Conditions
- Candiduria
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Investigators review patients' medical records and collect personal data, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence rate of Candiduria
the number of patients with Candiduria/ the number of all hospitalized patients
Measured: January 2015 to December 2017
morbidity rate of underlying diseases
the proportion of patients with every specific underlying disease
Measured: January 2015 to December 2017
indwelling catheter rate
the proportion of patients with indwelling catheter
Measured: January 2015 to December 2017
pyuria rate
the proportion of patients with pyuria
Measured: January 2015 to December 2017
Candiduria rate
the proportion of patients with Candiduria
Measured: January 2015 to December 2017
treatment rate
the proportion of patients with Candiduria treated with antifungal agents
Measured: January 2015 to December 2017
mortality rate
- the number of patients who die / the number of all hospitalized patients
- the number of patients who die from Candiduria/ the number of all hospitalized patients
Measured: January 2015 to December 2017
average indwelling catheter duration
The sum of indwelling catheter durations / the number of all hospitalized patients with Candiduria
Measured: January 2015 to December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 May 2019
- Primary completion31 Jul 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandiduriaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Ying-Chun, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910764
- Sponsor's protocol ID
- CE18273B
- Status last verified
- Oct 2020
- First submitted
- 7 Apr 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Surveillance Study of Candiduria in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT03910764
- Acronym / sponsor ID
- CE18273B
- Conditions
- Candiduria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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 explore the epidemiology, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis of patients with Candiduria.
Detailed description
The study is a retrospective study. Investigators will review medical records of patients with Candiduria from January 2015 to December 2017 to collect data about personal data, underlying diseases, indwelling catheter duration, laboratory data of urine routines and urine cultures, the symptom of fever, diagnosis, treatment and prognosis. After the data collection, investigators will run a descriptive statistics to find out the profile of the medical care of Candiduria in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with Candiduria
Key inclusion criteria (1 listed)
- patients with Candiduria
Key exclusion criteria (1 listed)
- patients without Candiduria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionInvestigators review patients' medical records and collect personal data, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis. | Other | – |
Primary outcome
prevalence rate of Candiduria
Time frame: January 2015 to December 2017
the number of patients with Candiduria/ the number of all hospitalized patients
morbidity rate of underlying diseases
Time frame: January 2015 to December 2017
the proportion of patients with every specific underlying disease
indwelling catheter rate
Time frame: January 2015 to December 2017
the proportion of patients with indwelling catheter
pyuria rate
Time frame: January 2015 to December 2017
the proportion of patients with pyuria
Candiduria rate
Time frame: January 2015 to December 2017
the proportion of patients with Candiduria
treatment rate
Time frame: January 2015 to December 2017
the proportion of patients with Candiduria treated with antifungal agents
mortality rate
Time frame: January 2015 to December 2017
1. the number of patients who die / the number of all hospitalized patients 2. the number of patients who die from Candiduria/ the number of all hospitalized patients
average indwelling catheter duration
Time frame: January 2015 to December 2017
The sum of indwelling catheter durations / the number of all hospitalized patients with Candiduria
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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.
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 Candiduria, run by Taichung Veterans General 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 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 8 Oct 2020. 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?
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?
prevalence rate of Candiduria (time frame: January 2015 to December 2017). The study lists 8 primary outcomes in all. 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 8 Oct 2020.