Pulmonary tuberculosis Infections and Infestations
Conditions
Interventions
This study is a prospective, longitudinal observational study, conducted at Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK. Participants will be recruited from the outp
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Aged 16 years or older 3. Engagement with the Leicester Clinical TB service with either suspected TB or active TB disease
Exclusion criteria
Exclusion criteria: 1. Any chronic medical disorder which, in the opinion of the investigator, may either put the subject at risk (because of participating in the study) or may influence the results of the study or the subjects’ ability to participate in the study 2. Donation of blood >450 ml within 3 months of study commencement or during the study (other than for study purposes). 3. Pregnancy or lactation 4. Participation in an interventional clinical study in the 3 months prior to of Visit 1 or participation in a study using interventional medicinal products in the previous 6 months 5. Previous chemotherapy for LTBI in the last 5 years 6. Previous treatment for active TB disease in the last 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbial diversity and composition measured using richness, Pilous evenness, Berger-Parker dominance, Shannon and Simpson indices to explore alpha diversity and Jaccard, Bray-Curtis and Unifrac measures to explore beta diversity, at before and after anti tuberculosis treatment (the standard duration of anti-tuberculosis treatment is 6 months; however, treatment may be extended to 9 or 12 months if response to treatment is considered unsatisfactory) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical responses measured using demographics, symptom burden, health-related quality of life (measured using EQ-5D-5L questionnaire), and lung function test with spirometry 2. Microbiological responses measured using smear status, Xpert grade, time to positive culture, molecular and phenotypic drug sensitivity 3. Radiological responses: CXR and CT to determine % lung involvement and evidence of extrapulmonary disease 4. Physiological and metabolic responses measured using physical activity monitoring (PAM), muscle function assessments (MFAs) with handgrip strength and quadriceps strength tests, muscle biopsy, body composition measurements with dual energy x-ray absorptiometry (DEXA) scan and bioelectrical impedance analysis (BIA) Measured at 2 weeks, 8 weeks, 16 weeks and 24 weeks after the anti-tuberculosis treatment start date and end of treatment. Participation at 6 months and 12 months after the treatment end date is optional. | — |
Countries
England, United Kingdom
Contacts
Public ContactPranabashis Haldar
Outcome results
None listed