Isoniazid (INH) Treatment Based on ELISPOT Assay

NCT01087190 | Completed DMC

• 1 other identifier: 2010-0009
• Study Type: interventional
• Target: 831
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

kidney; transplantation; tuberculosis; ELISPOT; isoniazid

Outcome Measures

Primary Outcomes (1)

• Development of tuberculosis (the rate of tuberculosis after transplantation)

  Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis

  3 years

Secondary Outcomes (3)

• All cause deaths

  3 years

• INH-associated adverse drug reactions

  3 years

• Graft failure

  3 years

Study Arms (3)

INH treatment group

EXPERIMENTAL

* randomly allocated to INH treatment group in renal transplant recipients with ELISPOT (+) * INH 300 mg po qd for 9 months

Drug: Isoniazid treatment

Control group

NO INTERVENTION

* randomly allocated to control group in renal transplant recipients with ELISPOT (+) * no treatment

Observation group

NO INTERVENTION

* allocated to observation group in renal transplant recipients with ELISPOT (-) * no treatment

Interventions

Isoniazid treatment DRUG

isoniazid 300 mg po qd for 9 months

INH treatment group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or more
• Kidney transplant recipients

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sung-Han Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 16, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

KR (1)