Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
A random allocation sequence will be generated in advance using computer-generated random numbers. This will be done by the study statistician. Randomisation will be 1:1 to the four arms of the trial
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years 2. Having TB symptoms (cough of any duration, fever, night sweats or weight loss) 3. Able to submit sputum 4. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1, Presence of clinical danger signs (unable to walk unaided, confused or agitated, breathless when speaking or at rest) 2. Already taking TB treatment, or taken TB treatment within the last 60 days 3. Unable to submit sputum and refuses offer of sputum induction 4. Previously been enrolled in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients initiating TB treatment within 28 days of enrolment compared between standard of care Xpert and Xpert Ultra arms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients diagnosed with TB initiating TB treatment within 28 days of enrolment between Standard Of Care and Xpert Ultra arms 2. Time from enrolment to TB treatment initiation between Standard Of Care and Xpert Ultra arms 3. All-cause mortality risk between Standard Of Care and Xpert Ultra arms 4. Proportion of patients diagnosed with bacteriologically-confirmed TB initiating TB treatment within 28 days of enrolment between chest radiography and no chest radiography arms | — |
Countries
Malawi
Contacts
Public ContactMadalo Mukoka
Outcome results
None listed