Diagnosis of active tuberculosis disease Respiratory
Conditions
Interventions
This will be an observational cohort study, recruiting patients who present to hospital with suspected active TB or acute pneumonia (control group). Consenting participants will have blood collected f
ii. one aliquot for interferon gamma release assay (IGRA) testing using QuantiFERON-TB Gold Plus (QFT)
iii. and one aliquot for Mtb blood culture. The consent and research visit will take place during the hospital stay for hospitalised patients.
Clinical investigations for TB will be i
respiratory sample microbiological testing (Xpert MTB/RIF Ultra, routine and mycobacterial culture) for expectorated samples
and chest X-ray. Demographic and clinical data will be systematically recorded on the study case report form.
The outcome of Actiphage testing will not be considered in the diagnosis
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to give informed consent to participate in the study 2. Aged 16 years or above, presenting with suspected pulmonary TB or acute community acquired pneumonia (CAP) and managed by Adult Services at University Hospitals of Leicester NHS Trust (UHL) 3. Recruitment of CAP patients will be selective and focus on: 3.1. Patients with a CXR that is coded for TB or mentions TB as a possibility in the report; AND / OR 3.2. Demographic matching (age and ethnicity) with recruited pulmonary TB cohort; AND / OR iii. patients with a clinical history of any red flag TB symptoms exceeding 2 weeks (cough, fever, night sweats, weight loss) persisting symptoms after a course of oral antibiotics
Exclusion criteria
Exclusion criteria: 1. Treated with anti-tuberculous medication at any time in previous 12 months 2. Participation in an interventional clinical study in the 3 months prior to Visit 1 or participation in a study using interventional medicinal products in the previous 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actiphage test for diagnosis of TB at a single time point. Diagnosis of TB is made according to standard clinical criteria based on microbiological, histological, and radiological evidence that is collected by reviewing patient medial notes. Actiphage test will be performed according to the manufacturer’s instructions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Agreement between Actiphage test results for contemporaneous samples tested at PBD laboratories and Leicester. Actiphage test will be performed according to the manufacturer’s instructions. | — |
Countries
England, United Kingdom
Outcome results
None listed