Comparison of three diagnostic tools for latent tuberculosis in haemodialysis patients
| ISRCTN | ISRCTN52111135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52111135 |
| Protocol serial number | N/A |
| Sponsor | Gachon University of Medicine and Science (South Korea) |
| Funder | Gachon University of Medicine and Science (South Korea) - Division of Nephrology, Department of Internal Medicine |
- 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 of protocol
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
| Primary study design | Observational |
|---|---|
| Study design | Single centre, observational, cross-sectional, open trial |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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(s) |
1. Skin test: positive or negative |
| Key secondary outcome measure(s) |
1. Skin test: size of induration |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 162 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 30/04/2008 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Division of Nephrology
Incheon
405-760
Korea, South
405-760
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
