RadioTB

What is this study about?

We aim to identify a shorter treatment regimen than the current six-month standard of care regimen for individuals with early states of tuberculosis (TB) whose chest X-rays suggest that they have the disease, but their diagnostic tests are negative.

There is increasing evidence to suggest that significant transmission of TB takes place by individuals that are asymptomatic. As a result, “active” case-finding using chest X-rays supported by computer-aided detection software is being rapidly scaled-up globally to mass-screen individuals for TB.

Among individuals who are screened with chest X-ray, approximately 5-7% have a chest X-ray suggestive of TB but their results on molecular testing are negative. These individuals are at high risk of progressing to clinical and infectious TB (approximately 10%/year). The optimal diagnostic and treatment approach for this group is unclear and in practice is highly variable.

Our overall goal is to provide strong evidence to guide policy for programmatic management and to advance understanding about this early TB state.

We will undertake the first randomised clinical trial in this population for over 30 years, using a pragmatic approach and an innovative duration response design to determine the shortest duration of the existing TB regimen required to prevent progression. In addition, we will evaluate the potential of new diagnostic approaches, model the impact on transmission, and evaluate the cost-effectiveness of the different management strategies.

 

Type of study

Randomised trial

Contact details

syed.zaidi.22@ucl.ac.uk

Data Sharing

Data will be available for sharing after trial closure. Researchers wishing to access Radio-TB data should contact the Trial Management Group in the first instance.

Who is funding the study?

RadioTB is funded by the Wellcome Trust.