The Safety, Completion Rate and Prevention Effect by Rifamycin-containing Regimens for Latent Tuberculosis Infection in Patients With Kidney Transplantation: a Prospective Intervention Pilot Study

NCT05588492 | Recruiting Phase 4

• 1 other identifier: 202110073MIND
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) remains the leading infectious disease worldwide and kidney transplant recipients (KTR) is high risk population needing prevention from reactivation, which cause high mortality. In fact, its latent tuberculosis infection (LTBI) is increasing after transplantation and has been identified as a risk factor for TB. However, the suitable regimen for LTBI treatment in KTRs remains unclear. Currently, three-month rifamycin-containing regimens, such as weekly rifapentine and isoniazid (3HP) or daily rifampicin and isoniazid (3HP), are common because its non-inferiority to nine-month of daily isoniazid (9H) and high completion rate by its short course in TB contacts. However, KTRs have many differences from general population, like use of immune-suppressants and possible residual renal insufficiency, so that to prescribe rifamycin-containing LTBI treatment regimens may have many concerns. One biggest concern is that drug-drug interaction between rifamycin and immunosuppressants. In addition, there is no study before in investigating the use of rifamycin-containing regimen in the population of KTRs (only study for kidney transplant candidates).

Conditions

Pulmonology

Keywords

latent tuberculosis infection,mycobacterium tuberculosis

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Incidence of treatment related any adverse event

  up to 12 months

Secondary Outcomes (1)

• Secondary Outcome Measure

  up to 12 months

Study Arms (2)

Rifamycin containing regimen

EXPERIMENTAL

Rifamycin containing regimen

Drug: Rifamycin-containing regimen

Rifamycin-free regimen

EXPERIMENTAL

Rifamycin-free regimen

Drug: Rifamycin-free regimen

Interventions

Rifamycin-containing regimen DRUG

Rifamycin-containing regimen

Rifamycin containing regimen

Rifamycin-free regimen DRUG

Rifamycin-free regimen

Rifamycin-free regimen

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received kidney transplant, and
• Will receive interferon-gamma release assay (IGRA) for LTBI, and
• If IGRA was positive, participants agree to receive LTBI treatment

You may not qualify if:

• Age \< 20 years old
• pregnancy
• Suspicious active tuberculosis

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Chin-Chung Shu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Chung Shu

CONTACT

+886-2312-3456; ccshu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: October 20, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 20, 2022

Record last verified: 2022-04

Locations

TW (1)