Tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to understand instructions in one of the commonly used languages. 2. To be a health care worker, defined broadly as a person working in a health care facility 3. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Currently on TB treatment or treated in the previous 6 months 2. Contraindicated for sputum induction a. Asthma, with acute exacerbation in last two weeks (any attack within the last two weeks) b. Dyspnea or respiratory distress, grade 3 or 4, in the last one week c. Hypoxemia (SpO2 <90% in ambient air) d. Hemoptysis (coughing up blood), in last one week e. History of esophageal operation f. Known eardrum damage or other middle ear lesions g. Acute sinusitis, with documentation h. Nosebleed, in the last week i. Nausea, grade 3 or 4, in the last two days j. Vomiting, grade 3 or 4, in the last two days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is sputum testability, defined as the proportion of participants who produce a testable sputum specimen (>1 mL) using each collection method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include sputum quality, diagnostic yield for TB testing, participant acceptability and tolerability, and frequency of procedure-related adverse events for Lung Flute ECO compared with spontaneous expectoration. | — |
Countries
Mozambique
Contacts
Coordination Investigator