TuberculosisNCT03736278
Characteristics of Tuberculosis Infection in Rheumatic Disease
An observational study of Tuberculosis and Autoimmune Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tuberculosis, Autoimmune Diseases
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Nov 2018to 24 Sep 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of rheumatic disease
Who may be able to join
- The patients with International Classification of Diseases (ICD) codes of rheumatic diseases during 2006-2017
- Definite evidence of tuberculosis infection
Who cannot join
- HIV, malignancy, not follow-up rheumatic disease in National Taiwan University Hospital, younger than 20-year-old, refusing attend research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Tuberculosis in Rheumatic Diseases for Epidemiology, Risk Factors, Disease Presentation, Complications, Treatment, and Prognosis
A retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease.
- Conditions
- Tuberculosis, Autoimmune Diseases
- Being tested
- No intervention
- Medical subject headings
- Tuberculosis, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
We group the patients according to the outcome (survival vs mortality)
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death of any cause (The definition of TB mortality from WHO is death of any cause during TB treatment.)
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start10 Nov 2018
- Primary completion30 Nov 2018
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiao-Feng Cheng, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736278
- Sponsor's protocol ID
- 201805069RIND
- Status last verified
- Jun 2018
- First submitted
- 4 Nov 2018
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Tuberculosis in Rheumatic Diseases for Epidemiology, Risk Factors, Disease Presentation, Complications, Treatment, and Prognosis
- ClinicalTrials.gov ID
- NCT03736278
- Acronym / sponsor ID
- 201805069RIND
- Conditions
- Tuberculosis, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 9 Nov 2018 (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.
A retrospective study evaluating the characteristics of tuberculosis infection in patients of rheumatic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of rheumatic disease
Key inclusion criteria (2 listed)
- The patients with International Classification of Diseases (ICD) codes of rheumatic diseases during 2006-2017
- Definite evidence of tuberculosis infection
Key exclusion criteria (1 listed)
- HIV, malignancy, not follow-up rheumatic disease in National Taiwan University Hospital, younger than 20-year-old, refusing attend research
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 interventionWe group the patients according to the outcome (survival vs mortality) | Other | – |
Primary outcome
Mortality
Time frame: approximately 6 months
Death of any cause (The definition of TB mortality from WHO is death of any cause during TB treatment.)
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 11 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Chiao-Feng Cheng, MD principal investigator
National Taiwan University 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 Tuberculosis and Autoimmune Diseases, run by National Taiwan University 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 2 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 11 Dec 2019. 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?
Mortality (time frame: approximately 6 months). 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 11 Dec 2019.