Tuberculosis
Conditions
Interventions
Video instructions for sputum production
Sponsors
Research Institute of Tuberculosis RIT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Symptoms suggestive of pulmonary TB and/or an abnormal chest X-ray Able and willing to provide written informed consent (>20 years) or minor assent (15-20) and parental consent for participants 15-20 years. Able to understand instructions in one of the four commonly used languages (English, French, Fulfulde, Pidgin)
Exclusion criteria
Exclusion criteria: • Asthma, with acute exacerbation in last two weeks (any attack within the last two weeks) • Dyspnea or respiratory distress, grade 3 or 4, in the last one week • Hypoxemia (SpO2 <90% in ambient air) • Hemoptysis (coughing up blood), in last one week • History of esophageal operation • Known eardrum damage or other middle ear lesions • Acute sinusitis, with documentation • Nosebleed, in the last one week • Nausea, grade 3 or 4, in the last two days • Vomiting grade 3 or 4, in the last two days • Other issue raised for exclusion based on the judgement of the clinical and/or study personnel Currently on TB treatment Inability to sit upright for 20 minutes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The estimated proportion of people who produce >1mL sputum after use of Lung Flute ECO as compared to after video instruction | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated TB testing results (Xpert MTB/RIF Ultra) for people asked to produce sputum ;Adverse events, with severity grading;Start of TB treatment Vital status a 2 months post-enrollment Tolerability of the Lung Flute ECO, visual analog scale ;Sputum quantity (=1mL, >1-2mL, 2-3mL, 3-4mL, >4mL) Sputum quality (Miller and Jones classification) | — |
Countries
Cameroon
Contacts
Public ContactSatoshi Mitarai
Research Institute of Tuberculosis
Outcome results
None listed