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MOZ-TUNE-TB - Mozambican Targeted Universal Non-invasive Evaluation for TB - A paired diagnostic comparison of Lung Flute ECO and spontaneous expectoration for targeted universal sputum sampling in Mozambican health care workers

Mozambican Targeted Universal Non-invasive Evaluation for TB - A paired diagnostic comparison of Lung Flute ECO and spontaneous expectoration for targeted universal sputum sampling in Mozambican health care workers (MOZ-TUNE-TB)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202606561497673
Enrollment
1590
Registered
2026-06-04
Start date
2026-07-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Spontaneous expectoration

Sponsors

The Research Institute of Tuberculosis Japan Anti Tuberculosis Association
Lead Sponsor
Institute of Tropical Medicine Antwerp Belgium
Collaborator

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactEllen M.H. Mitchell

Coordination Investigator

emitchell@itg.be+31634790509

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 10, 2026