Study to assess whether point-of-care lung ultrasound and patient factors are related to tuberculosis severity and disability

Formative prospective case–control study on Point-of-Care Lung Ultrasound and clinical–epidemiological factors to evaluate their association with Tuberculosis severity and predict disability (POCUS4TB-Peru)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15273350

Enrollment

400

Registered

2025-09-04

Start date

2026-02-03

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Tuberculosis Infections and Infestations

Interventions

This study will recruit adults living with TB attending health facilities (cases) and adults without TB living in the community (controls). The cases will be recruited from ongoing cohort (PREVENIR)

and (b) “respiratory community controls” who have been identified to have an acute respiratory infection (ARI) episode. In both cases and controls, after informed consent has been provided, a questio

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for cases: 1. Current participant of the PREVENIR study 2. Aged =18 years old 3. Receiving or will receive treatment for TB at the selected health centre Inclusion criteria for controls: 1. Current participant in the PRESIENTE study 2. Aged =18 years old

Exclusion criteria

Exclusion criteria: Exclusion criteria for cases: 1. Started treatment >2 weeks ago for the current TB episode 2. Serious illness resulting in an unstable condition or life-threatening participation in the study Exclusion criteria for controls: 1. Received TB treatment <1 year ago. 2. Serious illness resulting in an unstable condition or life-threatening participation in the study

Design outcomes

Primary

Measure	Time frame
Diagnostic performance of point-of-care ultrasound (POCUS) for detecting tuberculosis is measured in terms of sensitivity, specificity, positive predictive value, and negative predictive value, by comparing the interpretation of ultrasound images by two independent readers to bacteriologically and/or clinically confirmed TB at the baseline visit	—

Secondary

Measure	Time frame
1. Disability measured using EQ-5D-5L questionnaire at baseline and at 12 months 2. Quality of life measured using WHO BREF QO questionnaire and calculating quality-adjusted life years (QALYs) at baseline and at 12 months 3. Mortality measured through questionnaire to household members at 12 months 4. Cause of death evaluated through verbal autopsy conducted to household members of those deceased 5. Lung abnormalities suggestive of TB, measured using POCUS images interpreted by two independent readers in cases and controls at baseline and at 12 months 6. Disease severity measured using mycobacterial load in sputum samples at baseline and at 12 months	—

Measure

Time frame

1. Disability measured using EQ-5D-5L questionnaire at baseline and at 12 months 2. Quality of life measured using WHO BREF QO questionnaire and calculating quality-adjusted life years (QALYs) at baseline and at 12 months 3. Mortality measured through questionnaire to household members at 12 months 4. Cause of death evaluated through verbal autopsy conducted to household members of those deceased 5. Lung abnormalities suggestive of TB, measured using POCUS images interpreted by two independent readers in cases and controls at baseline and at 12 months 6. Disease severity measured using mycobacterial load in sputum samples at baseline and at 12 months

—

Countries

Peru

Contacts

Public ContactCarlos;Sumona Lou;Datta

;

carlos.a.lou.dan@gmail.com;sumo.datta31@gmail.com+51 (0)1 2090400;+51 (0)1 2090400

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026