'The effect of two treatment regimens: weekly rifapentine and isoniazid (3HP), compared to 4 months of daily rifampicin (4RIF) on adherence to treatment for latent tuberculosis

Not Applicable

Recruiting

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

• Registration Number: ACTRN12618001672246
• Lead Sponsor: Royal Prince Alfred Hospital, Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-10
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1.Patients aged greater than or equal to 2 years old.
2.Eligible for treatment for LTBI, by either:
a.A TST of 10mm or greater, or
b.A positive Interferon Gamma Release Assay (IGRA), or
c.A negative TST in the presence of HIV infection in a contact of a person with confirmed tuberculosis infection.
3.Access to EITHER a mobile phone OR landline telephone (people who cannot use phone will be called instead of SMS).

Exclusion Criteria

1.Presumptive tuberculosis in which TB has not been excluded
2.Confirmed tuberculosis.
3.Treatment for active tuberculosis.
4.History of isoniazid and/or rifampicin resistant tuberculosis.
5.Tuberculosis in the source case (i.e. ‘index’ case) known to be resistant to either isoniazid or rifampicin at the time of enrolment.
6.History of hypersensitivity to isoniazid, rifapentine, or rifamycins.
7.Medical conditions requiring the use of medication interacting with study medication
8.Weight of the participant < 10.0 kg
9.Currently pregnant, planning to become pregnant, or breastfeeding.
10.Consideration for solid organ transplantation.
11.Unable to give informed consent
12.AST over 3 times the upper limit of normal.
13.Known porphyria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the proportion of patients completing treatment with a three-month (12-dose) regimen of weekly rifapentine and isoniazid (intervention arm), supported by SMS, compared to the 120 dose regimen of daily self-administered rifampicin (control arm) to treat LTBI.<br><br>Primary outcome: <br>Treatment completion. Treatment completion is defined as taking at least 90% of the doses within the treatment period plus one month, based upon monthly pill count by healthcare workers. i.e. for the 3HP arm, this comprises greater than or equal to 11 doses taken within 16 weeks of enrolment for the 3HP arm, For the 4RIF arm, this comprises at least 108 of 120 doses taken within 5 months. <br>[Treatment completion will be accessed within the treatment period plus one month]