NCT03736278

Brief Summary

A retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

November 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

December 11, 2019

Status Verified

June 1, 2018

Enrollment Period

20 days

First QC Date

November 4, 2018

Last Update Submit

December 8, 2019

Conditions

TuberculosisAutoimmune Diseases

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death of any cause (The definition of TB mortality from WHO is death of any cause during TB treatment.)

    approximately 6 months

Interventions

No interventionOTHER

We group the patients according to the outcome (survival vs mortality)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients of rheumatic disease

You may qualify if:

  • The patients with International Classification of Diseases (ICD) codes of rheumatic diseases during 2006-2017
  • Definite evidence of tuberculosis infection

You may not qualify if:

  • HIV, malignancy, not follow-up rheumatic disease in National Taiwan University Hospital, younger than 20-year-old, refusing attend research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

TuberculosisAutoimmune Diseases

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsImmune System Diseases

Study Officials

  • Chiao-Feng Cheng, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 9, 2018

Study Start

November 10, 2018

Primary Completion

November 30, 2018

Study Completion

September 24, 2019

Last Updated

December 11, 2019

Record last verified: 2018-06

Locations

TW(1)