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Isoniazid (INH) Treatment Based on ELISPOT Assay

NCT01087190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2013-12-12

No results posted yet for this study

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.

Conditions

  • Kidney Transplant Recipient

Interventions

DRUG

Isoniazid treatment

isoniazid 300 mg po qd for 9 months

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Sung-Han Kim, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-05-31
Completion
2013-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087190 on ClinicalTrials.gov