Condition category
Infections and Infestations
Date applied
18/03/2008
Date assigned
26/03/2008
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jaeseok Yang

ORCID ID

Contact details

Division of Nephrology
Department of Internal Medicine
Gil Medical Center
1198 Guwol-dong
Namdong-gu
Incheon
405-760
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Latent tuberculosis is hard to diagnose in immunocompromised hosts like haemodialysis patients, and widespread bacille calmette-guerin (BCG) vaccination make it complicated to interpretate Mantoux test results in Korea. Therefore, we need more sensitive and specific diagnostic tools for latent tuberculosis in haemodialysis patients.

Hypothesis:
T-spot assay or Quantiferon assay is more sensitive and specific than Mantoux test for latent tuberculosis in haemodialysis patients.

Ethics approval

Ethics approval received from the Institutional Review Board (IRB) of Gachon University of Medicine and Science on the 28th February 2008 (ref: 20080228 tuberculosis in haemodialysis).

Study design

Single centre, observational, cross-sectional, open trial

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please contact Jaeseok Yang at jcyjs@hanafos.com to request a patient information sheet

Condition

Latent tuberculosis

Intervention

Agreement of three diagnostic tests for latent tuberculosis will be tested in haemodialysis patients. Blood samples are taken for:
1. Quantiferon-gold assay, an enzyme linked immunosorbent assay (ELISA) assay for interferon gamma in response to tuberculosis specific antigens
2. T-spot assay, an enzyme-linked immunosorbent spot (ELISPOT) assay for interferon gamma

After sampling, the Mantoux test will be performed, and the results will be read in two days. Agreement of three test results will be analysed using kappa coefficients, and results will be analysed per each categories of risk groups such as low risk group, casual contact group, latent tuberculosis patients, and active tuberculosis patients. Agreement will be also analysed in medical staff group with normal immunity.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Skin test: positive or negative
2. Quantiferon-gold: positive or negative
3. T-spot test: positive or negative

These outcomes will be measured on the day of testing.

Secondary outcome measures

1. Skin test: size of induration
2. Quantiferon-gold: concentration
3. T-spot test: number, mean area

These outcomes will be measured on the day of testing.

Overall trial start date

01/03/2008

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic maintenance haemodialysis patients who continue to receive haemodialysis for more than three months in the Gil Medical Centre
2. Older than 18 years, and less than 80 years, either sex
3. Agrees to participate in this trial
4. Medical staff in the haemodialysis centre of the Gil Medical Centre

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

162

Participant exclusion criteria

1. Patients who suffer from skin diseases which may interfere with Mantoux test
2. Patients with an active infection, except tuberculosis
3. Patients who cannot make independent decision due to mental disorders

Recruitment start date

01/03/2008

Recruitment end date

30/04/2008

Locations

Countries of recruitment

Korea, South

Trial participating centre

Division of Nephrology
Incheon
405-760
Korea, South

Sponsor information

Organisation

Gachon University of Medicine and Science (South Korea)

Sponsor details

Institutional Review Board (IRB)
Department of Pharmacy
Gil Medical Centre
1198 Guwol-dong
Namdong-gu
Incheon
405-760
Korea
South

Sponsor type

University/education

Website

http://home.gachon.ac.kr/icc/

Funders

Funder type

University/education

Funder name

Gachon University of Medicine and Science (South Korea) - Division of Nephrology, Department of Internal Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes