Short-course Isoniazid and Rifapentine for Cost-effective Latent tuberculosis Eradication

Randomised controlled trial for cost-benefit of short-course isoniazid and rifapentine versus 9-month course of isoniazid in latent tuberculosis infection

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000599774

Acronym

SIRCLE (Short-course Isoniazid and Rifapentine for Cost-effective Latent tuberculosis Eradication)

Enrollment

Registered

2013-05-27

Start date

2013-12-06

Completion date

2015-06-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to perform a multimodal comparison of 3-month courses of weekly isoniazid and rifapentine (3HR) with 9 months of daily isoniazid (9H) for latent tuberculosis infection, using a variety of indices: a. Cost-benefit b. Patient satisfaction c. Adherence to prescribed therapy

Interventions

A 12 dose course of weekly isoniazid (900mg) and rifapentine (900mg) tablets.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Males and non-pregnant, non-breastfeeding females Weight > 45kg Willingness to provide signed informed consent. Sufficient English-language skills for informed consent. Clinical indication for latent tuberculosis infection (LTBI) treatment. 1) Person with a positive interferon-gamma release assay (IGRA) (defined as >0.35 IU/mL TB antigen-Nil) AND one of the following: close contact to someone with culture confirmed TB or from a high-risk background, current or planned immunosuppressive therapy, or calcification on chest X-ray and no prior history of TB treatment; 2) IGRA converters defined as a documented change from negative to positive within a two-year period; 3) Persons with any other clinical indication for LTBI treatment including persons with a negative IGRA (eg high risk clinical history and pending immunosuppressive therapy)

Exclusion criteria

Confirmed or suspected active TB disease Contacts to a source case with known resistance to isoniazid and/or rifampicin Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB. History of allergy or intolerance to isoniazid or rifamycins Serum alanine aminotransferase (ALT) > 100 IU/L

Outcome results