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Surveillance Study of Candiduria in Hospitalized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03910764
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Chen Ying-Chun, Taichung Veterans General Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Candiduria Other: no intervention

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
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Study Type : Observational
Actual Enrollment : 536 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Surveillance Study of Candiduria in Hospitalized Patients
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : September 16, 2020
Groups and Cohorts
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Intervention Details:
  • Other: no intervention
    Investigators review patients' medical records and collect personal data, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis.

Outcome Measures
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Primary Outcome Measures :
  1. prevalence rate of Candiduria [ Time Frame: January 2015 to December 2017 ]
    the number of patients with Candiduria/ the number of all hospitalized patients

  2. morbidity rate of underlying diseases [ Time Frame: January 2015 to December 2017 ]
    the proportion of patients with every specific underlying disease

  3. indwelling catheter rate [ Time Frame: January 2015 to December 2017 ]
    the proportion of patients with indwelling catheter

  4. pyuria rate [ Time Frame: January 2015 to December 2017 ]
    the proportion of patients with pyuria

  5. Candiduria rate [ Time Frame: January 2015 to December 2017 ]
    the proportion of patients with Candiduria

  6. treatment rate [ Time Frame: January 2015 to December 2017 ]
    the proportion of patients with Candiduria treated with antifungal agents

  7. 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

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients with Candiduria
Criteria

Inclusion Criteria:

  • patients with Candiduria

Exclusion Criteria:

  • patients without Candiduria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910764


Locations
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Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Taichung Veterans General Hospital
More Information
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Responsible Party: Chen Ying-Chun, infection preventionist, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT03910764    
Other Study ID Numbers: CE18273B
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No