UK-based tuberculosis treatment trial recruits first participant
05 Jul 2023
A clinical trial aiming to find better ways of treating latent tuberculosis (TB) has launched in the UK. The RID-TB: Treat trial, which will assess two newly-shortened treatment regimens along with additional treatment support, recruited its first participant last week at the Royal Free Hospital in London.
TB is caused by a bacterial infection, which can lay dormant as latent TB for months or years before symptoms appear. Treating latent TB is crucial to reducing the global burden of TB and eliminating it entirely from countries with low TB rates like the UK. Standard treatment in the UK usually involves three months of self-administered, daily treatment. While this is effective at preventing active TB developing, its success is limited as patients often struggle to complete their regimens.
RID-TB: Treat will investigate whether taking medicines less frequently or for a shorter period can help patients better stick to their treatment plan than the current three-month regimen with daily dosing.
The trial will also assess the effect of additional support to help patients stick to their treatment regimens, compared with routine support. Routine support consists of an animated video and leaflet with information about latent TB infection and the importance of completing treatment. On top of this, the additional support groups will get reminders in the form of audio alarms or text messages if they do not take their medication on time.
Researchers will randomise participants across four arms:
- three months of daily isoniazid plus rifampicin (3HR), with routine treatment support (current standard-of-care),
- three months of daily isoniazid plus rifampicin (3HR), with additional support,
- three months of weekly isoniazid plus rifapentine (3HP), with additional adherence support,
- one month of daily isoniazid plus rifapentine (1HP), with routine treatment support.
The team will compare the proportion of participants in each group who take at least 90% of their allotted doses within the allowed timeframe. They will monitor this using electronic pillboxes which record the date and time of each opening.
The trial is open-label, meaning both the researchers and participants will know which drug regimen and level of support each patient receives.
RID-TB: Treat is open to people aged 16-65 who are eligible for latent TB infection treatment. In the UK, this is mainly the contacts of people with diagnosed active TB and new migrants to the UK from countries where TB is common. Researchers will recruit participants from hospital and community care services.
The first stage of the trial aims to recruit 400 participants and the team hope to have the first set of results by December 2024.
RID-TB: Treat is part of a five-year programme, RID-TB, funded by the National Institute for Health and Care Research (NIHR).
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