NCT03910764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

April 7, 2019

Last Update Submit

October 5, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • prevalence rate of Candiduria

    the number of patients with Candiduria/ the number of all hospitalized patients

    January 2015 to December 2017

  • morbidity rate of underlying diseases

    the proportion of patients with every specific underlying disease

    January 2015 to December 2017

  • indwelling catheter rate

    the proportion of patients with indwelling catheter

    January 2015 to December 2017

  • pyuria rate

    the proportion of patients with pyuria

    January 2015 to December 2017

  • Candiduria rate

    the proportion of patients with Candiduria

    January 2015 to December 2017

  • treatment rate

    the proportion of patients with Candiduria treated with antifungal agents

    January 2015 to December 2017

  • mortality rate

    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

    January 2015 to December 2017

  • average indwelling catheter duration

    The sum of indwelling catheter durations / the number of all hospitalized patients with Candiduria

    January 2015 to December 2017

Interventions

Investigators review patients' medical records and collect personal data, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with Candiduria

You may qualify if:

  • patients with Candiduria

You may not qualify if:

  • patients without Candiduria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
infection preventionist

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 10, 2019

Study Start

May 1, 2019

Primary Completion

July 31, 2020

Study Completion

September 16, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations