A15 A16
Conditions
Interventions
Group 1: Patients with presumed tuberculosis will provide sputum, one tongue swab, and two breath samples using (i) a blowtube-based breath collection device and (ii) a face mask breath collection dev
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients will be included for the first objective of the study if they meet the following criteria: • seek care at an ambulatory site associated with the IPMN; • are adults =18 years of age; • have a cough for two or more weeks, with or without any other feature of TB (e.g., fever, night sweats, weight loss, or radiological findings consistent with TB); • provide informed consent For the secondary objectives, #4 and #5, participants will be selected if they: • are healthcare workers or related stakeholders for the respiratory diagnosis process • are patients who have used both sampling devices in this study • provide consent to being interviewed and recorded
Exclusion criteria
Exclusion criteria: • have completed latent or active TB treatment within the past 12 months • have taken any medication with anti-mycobacterial activity (including fluoroquinolones) within two weeks of study entry • unable to provide sputum samples • informed consent is not provided
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to explore the early performance (sensitivity, specificity and diagnostic yield) of the exhaled breath aerosol (XBA) sampling devices with molecular testing in intended use settings when compared to a sputum culture and molecular-based microbiological reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| This study has the following secondary objectives: 1. To assess diagnostic accuracy of XBA sampling for detecting drug resistance mutations (rifampicin resistance) compared to a microbiological reference standard. 2. To assess the diagnostic accuracy of the XBA sampling devices with molecular tests for TB to a composite reference standard. 3. To compare the clinical performance (sensitivity, specificity, diagnostic yield) of the XBA sampling devices with other sampling methods (e.g. sputum and tongue swab). 4. To evaluate the acceptability and usability of the XBA sampling devices from the perspective of healthcare workers, lab personnel and patients. 5. To evaluate the operational feasibility of implementing the innovations into routine clinical care. | — |
Countries
Romania
Contacts
Public ContactClaudia Denkinger
University Hospital Heidelberg
Outcome results
None listed