Isoniazid (INH) Treatment Based on ELISPOT Assay

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Isoniazid

Criteria

Inclusion Criteria:

• 16 years or more

• Kidney transplant recipients

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

1. Close contact with a person with pulmonary TB within the past year

2. Abnormal chest radiography and no prior prophylaxis

3. A history of untreated or inadequately treated TB

4. New infection (i.e. a recent conversion of TST to positive status)

• If kidney transplant donor has these clinical risk factors for latent tuberculosis infection, the transplant recipient from this donor will be excluded from this study.