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It has been recommended that all transplant recipients undergo a tuberculin skin test (TST) before transplantation. However, the ability of TST to diagnose latent tuberculosis infection (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT) detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave promising results in immunocompromised patients as well as in immunocompetent patients. The investigators will perform a randomized, open-label, prospective trial of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.
Our previous data have shown that ELISPOT assay was more sensitive to detect LTBI in renal transplant recipients than TST (Kim SH, et al. Transplant Infect Dis 2010 Jan 25 [Epub ahead of print]). However, further studies are eagerly awaited to determine the efficacy of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients. All adult patients admitted for renal transplantation between May 2010 and April 2013 at the Asan Medical Center, Seoul, South Korea, will be prospectively enrolled. INH (300 mg/day for 9 months) prophylaxis group and no prophylaxis group (control group) will be randomly assigned to all patients with a baseline positive ELISPOT assay regardless of the results of TST. The investigators will compare cumulative probability of developing active TB after transplantation between INH prophylaxis group and control group as primary outcome. Secondary outcomes will be adverse drug reactions, rejection episodes, graft survival, and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INH treatment group | Experimental |
|
|
| Control group | No Intervention |
| |
| Observation group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoniazid treatment | Drug | isoniazid 300 mg po qd for 9 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of tuberculosis (the rate of tuberculosis after transplantation) | Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| All cause deaths |
| 3 years |
| INH-associated adverse drug reactions | liver function abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Patients who do not receive isoniazid treatment due to abnormal liver function (i.e. Child-Pugh Score B or C)
Patients who have clinical risk factors for latent tuberculosis infection
Close contact with a person with pulmonary TB within the past year
Abnormal chest radiography and no prior prophylaxis
A history of untreated or inadequately treated TB
New infection (i.e. a recent conversion of TST to positive status)
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Han Kim, MD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| 3 years |
| Graft failure | 3 years |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |