Evaluating the performance of blood-based test (Actiphage test) for active tuberculosis
- Conditions
- Diagnosis of active tuberculosis diseaseRespiratory
- Registration Number
- ISRCTN18158855
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 103
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.