Implementing shorter treatment for latent tuberculosis in the Northern Territory

Phase 4

Recruiting

• Conditions: Tuberculosis; Latent tuberculosis infection; Infection - Studies of infection and infectious agents; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12619001704189
• Lead Sponsor: TB Unit, Northern Territory Centre for Disease Control

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-04
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Patients with latent tuberculosis infection diagnosed by positive tuberculin skin test (TST) or Interferon-Gamma Release Assay (IGRA), in whom active TB disease has been excluded, and there is a clinical indication for treatment of latent tuberculosis infection.

Exclusion Criteria

Children less than two years of age or body weight less than 10kg

Anyone with presumed or confired TB disease or is undergoing treatment for TB disease

Those with presumed infection with isoniazid or rifampicin resistant Mycobacterium tuberculosis

Pregnant women or women who expect to become pregnant during the twelve week course of treatment

Those taking any medication which may result in a clinically significant interaction with isoniazid or rifapentine, including people with HIV infection taking antiretroviral medications which may interact with rifapentine such as protease inhibitors or nevirapine.

Those with a history of allergic reaction or hypersensitivity to isoniazid, rifapentine or rifamycins

Those with a AST level that is three or more times higher than the upper limit of normal

Anyone under consideration for solid organ transplantation

Anyone with a history of porphyria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment completion rate. Treatment completion will be assessed by clinic staff through review of patient medication tracker and pill count. <br><br>For 3HP, treatment completion is defined as at least 12 valid doses (more than 72 hours apart) of rifapentine and isoniazid within 16 weeks.<br><br>For 9H, treatment completion is defined as 270 daily doses or 117 thrice weekly doses, taken within 12 months.[End of treatment]

Secondary Outcome Measures

Name	Time	Method
Qualitative assessment of patient satisfaction with latent tuberculosis treatment. Patient satisfaction will be assessed through the use of semi-structured interview including visual analogue scales and qualitative assessment of open ended questions around satisfaction with treatment. [End of treatment];Qualitative assessment of treatment provider satisfaction with latent tuberculosis regimens. Provider satisfaction will be assessed using an web-based survey including visual analogue scales and qualitative assessment of open ended questions. [End of trial];Cost-effectiveness of 3HP versus 9H for treatment of latent tuberculosis infection from the healthcare perspective. Hospital medical records will be used to gather data on the resource use and cost associated with both regimens. This will be assessed for each treatment regimen as cost in AUD per patient completing therapy. [End of trial]