Point-of-care ultrasound for tuberculosis in children in Mozambique

Point-of-care ultrasound for tuberculosis in children in mozambique: preliminary phase

Registry ID
ISRCTN10369960
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
London School of Hygiene & Tropical Medicine
Enrollment
250
Start date
2025-12-01
Completion date
2027-03-01
Last update
2026-08-17

Conditions

Summary

Tuberculosis

Detailed description

The study will enrol children <15 years with signs or symptoms suggestive of TB attending health facilities. Those meeting the inclusion criteria and consenting will be enrolled. Clinical assessment, clinical history, and physical examination (including anthropometric measures such as height, weight, and MUAC) will be performed. Respiratory samples (spontaneous or sputum induction) and gastric aspirates will be collected for GeneXpert and culture testing, along with stool samples. All participants will undergo a Point-Of-Care UltraSound (POCUS) examination and a Chest X-Ray (CXR). Children will be tested for HIV if they have an unknown HIV status. For children living with HIV, a urinary LAM, CD4 and viral load will also be performed. Follow-up visits at 2 and 6 months after enrolment will be conducted. Clinical information and anthropometric measurements will be collected at each visit, and, if the participant is still symptomatic, microbiological TB testing (Gene Xpert and culture) will be repeated. At each follow-up visit, POCUS and CXR evaluation will be conducted in all participants who had initiated treatment. For those who started TB treatment later than baseline, an end-of-treatment visit will be performed.

Interventions

Inclusion criteria

Children <15 years of age presenting at health facilities with either: 1. Chronic, well-defined symptoms: 1.1. Persistent cough: more than 2 weeks 1.2. Weight loss/failure to thrive 1.3. Persistent unexplained fever: for >1 week and > 38°C 1.4. Persistent, unexplained lethargy or reduced playfulness 1.5. Infants 0 – 60 days: 1.5.1. Neonatal pneumonia 1.5.2. Unexplained hepatosplenomegaly 1.5.3. Sepsis-like illness or 2. Any duration of cough/wheeze/acute pneumonia plus any of the following: 2.1. Chest X-ray compatible with TB as interpreted by the treating physician 2.2. A history of contact with a TB patient in the last two years

Exclusion criteria

Participants will be excluded if: 1. History of TB treatment in the last year 2. Parents refused to provide consent for study participation or HIV testing when the status is unknown 3. Severe illness resulting in an unstable condition

Locations

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