NCT06944561

Improved Diagnostics for Paediatric Tuberculosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: St George's, University of London · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Improved diagnostics for paediatric Tuberculosis

Detailed description

Research Question: To test the feasibility of TiKa system to reliably detect Mycobacterium tuberculosis in faeces of paediatric patients with Tuberculosis Study Design: Non-randomised diagnostic proof of concept feasibility study Study Participants: Patients with or suspected to have Tuberculosis

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Culture and identify Mycobacterium tuberculosis from patient faeces	When faecal samples have been identified only by a pseudo-anonymised label they will be transferred to the designated secure collection point (Vaccine Institute). Professor Tim Bull will then be informed of their availability and will collect and transport to the research laboratory, located in the same building, making a log of all samples received. All samples will then be processed by the research laboratory as defined in the sample processing protocol. Culture result data will be obtained and stored on a secure password protected PC Excel file for collation and archiving by the chief analyst.

Timeline

• Start date: 2021-10-04
• Primary completion: 2024-02-02
• Completion: 2024-02-02
• First posted: 2025-04-25
• Last updated: 2025-04-25

Locations

1 site across 1 country: United Kingdom