Persist-TB
Research type
Research Study
Full title
Novel culture methods for detecting persistent Mycobacterium tuberculosis in patient samples
IRAS ID
300201
Contact name
Catherine Cosgrove
Contact email
Sponsor organisation
St Georges University
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Mycobacterium tuberculosis culture from patient tissue samples is the gold standard diagnostic test for tuberculosis disease, and positive culture is necessary to allow antibiotic sensitivities to be derived in the laboratory. Conventional culture is slow (up to 42 days) and positive in only 75% of clinically diagnosed tuberculosis. The addition of mycobcterial culture supernatant (which is known to contain TB growth factors) may decrease the time to positive culture and increase the proportion of samples that produce a positive culture. This study will trial the culture supernatant method compared with the conventional method to see if the speed and proportion of positive cultures can be increased. Patients diagnosed with clinical pulmonary tuberculosis (the most common disease type) will submit 2 paired sputum samples at regular time periods in this study. One of each pair of samples will have conventional culture and the other the experimental culture. Statistical analysis will demonstrate which method is the fastest and most sensitive. Patients with TB disease at other anatomical sites (extra-pulmonary disease) will also be invited to the study, but in this case only excess diagnostic tissue samples from the laboratory will be used. No additional procedures or material will be taken from patients with extrapulmonary disease for study purposes. If they have pulmonary disease as well as extra-pulmonary disease, extra sputum will still be requested.
REC name
London - Bromley Research Ethics Committee
REC reference
22/PR/0269
Date of REC Opinion
7 Apr 2022
REC opinion
Favourable Opinion