Tuberculosis
Conditions
Interventions
Spontaneous expectoration standard of care
Sponsors
Research Institute of Tuberculosis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - People who have screened positive following computer-assisted dCXR-CAD. - Age = 12 years - Willing and able to provide informed consent (or in the case of minors informed assent and parental consent).
Exclusion criteria
Exclusion criteria: - People who are contraindicated for vigorous expectoration attempts (see below). - Currently taking TB treatment or completing within the previous 6 months. - Children <12 years of age People who are contraindicated for vigorous expectoration attempts are those meeting any of the following criteria: 1. Asthma, with acute exacerbation in last two weeks (any attack within the last two weeks) 2. Dyspnea or respiratory distress, grade 3 or 4, in the last one week 3. Hypoxemia (SpO2 <90% in ambient air) 4. Hemoptysis (coughing up blood), in last one week 5. History of esophageal operation 6. Known eardrum damage or other middle ear lesions 7. Acute sinusitis, with documentation 8. Nosebleed, in the last one week 9. Nausea, grade 3 or 4, in the last two days 10. Vomiting, grade 3 or 4, in the last two days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: 33% relative increase in diagnostic yield of pulmonary TB (absolute 2% increase: 6% PTB prevalence in those randomized to spontaneously expectorate (SE) ? 8% PTB prevalence in users of LFE). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Test coverage: Estimated 20% increase in the proportion who submit a viable sample following use of LFE (55% to 75%) - Cost-Effectiveness: Estimated $5–$7 incremental cost per additional case detected. - Operational: Demonstrated feasibility of LFE in high-volume ACF settings. (e.g. time to sputum production) | — |
Countries
South Africa
Contacts
Public ContactJody Boffa
Co Investigator
Outcome results
None listed