Tuberculosis Respiratory Paediatrics
Conditions
Interventions
Microbiological Clinical and Radiological Data Collection from Adults and Children
Sponsors
Gates Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult TB: • Age = 18 years • Symptoms suggestive of TB (e.g., cough >2 weeks, weight loss, fever, night sweats) OR Known TB contact in the past 12 months with or without symptoms OR Person living with HIV (PLHIV) under TB evaluation with or without symptoms with available chest radiograph Adult Pneumonia: • Age = 18 years • Acute respiratory symptoms and signs (new or increased) (e.g., cough +/- fever +/- dyspnoea +/- pleuritic chest pain + tachypnoea or respiratory distress) suggestive of pneumonia Paediatric TB: • Age 2 weeks, weight loss/ failure to thrive) OR Known TB contact in the past 12 months with or without symptoms OR Child living with HIV (CLHIV) under TB evaluation with or without symptoms Paediatric Pneumonia: • Age < 18 years • Acute respiratory symptoms (e.g., cough or difficulty breathing AND chest indrawing AND/ OR tachypnoea) Chest radiographs must be available for all participant categories.
Exclusion criteria
Exclusion criteria: Adult TB: • Medical instability per treating clinician’s discretion (e.g., requiring immediate resuscitation or airway support) • Physical barriers to ultrasound (e.g bandages, chest tube, skin infection, open wound etc.) • Patients who have been on Anti-TB treatment (ATT) during the past 6 months • Patients on ATT for >1 week* Adult Pneumonia: • Nosocomial pneumonia (onset >48 hours after admission) • Medical instability per treating clinician’s discretion (e.g., requiring immediate resuscitation or airway support) • Physical barriers to ultrasound (e.g bandages, chest tube, skin infection, open wound etc.) • >24 hours since antibiotic initiation for pneumonia • Aspiration pneumonia due to any reason. The inability to consent is an exclusion criteria for all adult participants. Paediatric TB: • Patients who have been on ATT during the past 6 months • Patients on ATT for >2 weeks* • Medical instability per treating clinician’s discretion (e.g., requiring immediate resuscitation or airway support) • Physical barriers to ultrasound (e.g bandages, chest tube, skin infection, open wound etc.) Paediatric Pneumonia: • >24 hours since antibiotic initiation for pneumonia • Medical instability per treating clinician’s discretion (e.g., requiring immediate resuscitation or airway support) • Physical barriers to ultrasound (e.g bandages, chest tube, skin infection, open wound etc.) Lack of parental or guardian consent is an exclusion for both paediatric participant categories.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To create an open-source, geographically diverse database comprising TUS images and cine clips, paired with digital CXR and HRCT (in adults), along with annotations, reports, clinical information, respiratory sounds captured through digital stethoscopes, demographics, lab results, and supporting evidence toward final diagnoses of TB and community acquired pneumonia. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To develop and test the feasibility of prototype AI-enabled CAD models for the automated interpretation of POCUS-based TUS images for the triage and detection of radiological signs of TB and community acquired pneumonia in adults and children. | — |
Countries
India, Nigeria, South Africa
Contacts
Public ContactCynthia Baard
Project Manager
Outcome results
None listed