Comparison of three diagnostic tools for latent tuberculosis in haemodialysis patients
| ISRCTN | ISRCTN52111135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52111135 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/03/2008
- Registration date
- 26/03/2008
- Last edited
- 26/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Jaeseok Yang
Scientific
Scientific
Division of Nephrology
Department of Internal Medicine
Gil Medical Center
1198 Guwol-dong
Namdong-gu
Incheon
405-760
Korea, South
Study information
| Study design | Single centre, observational, cross-sectional, open trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please contact Jaeseok Yang at jcyjs@hanafos.com to request a patient information sheet |
| Scientific title | |
| 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(s) | 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). |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2008 |
| Overall study end date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 162 |
| 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 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
Study participating centre
Division of Nephrology
Incheon
405-760
Korea, South
405-760
Korea, South
Sponsor information
Gachon University of Medicine and Science (South Korea)
University/education
University/education
Institutional Review Board (IRB)
Department of Pharmacy
Gil Medical Centre
1198 Guwol-dong
Namdong-gu
Incheon
405-760
Korea, South
| Website | http://home.gachon.ac.kr/icc/ |
|---|---|
"ROR" |
https://ror.org/03ryywt80 |
Funders
Funder type
University/education
Gachon University of Medicine and Science (South Korea) - Division of Nephrology, Department of Internal Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
