Bedaquiline for nontuberculous mycobacterial disease in the UK
Research type
Research Study
Full title
The use of bedaquiline in the treatment of nontuberculous mycobacterial disease in the United Kingdom
IRAS ID
327253
Contact name
Onn Min Kon
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Nontuberculous mycobacteria (NTM) are found throughout the environment and may cause infection at various sites within the body. The most common site is the lungs, but they can also affect extrapulmonary sites such as the skin, bones, joints, gastrointestinal system and central nervous system. While NTM do not usually cause infections in healthy individuals, people with underlying chronic lung diseases, genetic conditions or impaired immune systems may be at increased risk. Diagnosing NTM disease is challenging. Treating NTM infections requires prolonged courses of multiple antibiotics that often have several side effects and may not be successful. It is therefore important to explore whether new treatments could be effective at treating NTM infections when first-line drug regimens are unsuccessful.
Bedaquiline is an antibiotic that is licensed for the treatment of multidrug resistant tuberculosis. Laboratory studies have shown that bedaquiline may also be effective against NTM infections. However there are currently no data from clinical trials regarding the effectiveness of bedaquiline in treating NTM infections in humans. There are a very limited number of published case reports and case series that suggest bedaquiline may be beneficial in treating NTM infections in certain circumstances, but it remains unclear which groups of patients with NTM infection may benefit from its use.
In this study, we are aiming to develop the evidence base through a UK-wide case series on the use of bedaquiline to treat both pulmonary and extrapulmonary NTM infections. We will collate and analyse the clinical histories and outcomes of patients who have already been treated with bedaquiline for NTM infection. This in turn will provide a greater understanding of when its use in NTM treatment regimens should be considered. This will the first case series on bedaquiline use for NTM infections in the UK and will help to inform national guidance.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
23/EM/0229
Date of REC Opinion
20 Oct 2023
REC opinion
Further Information Favourable Opinion