Improved Diagnostics for Paediatric Tub… | Clinical Trial

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIU Office, St George's NHS Healthcare Trust

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any patient under the age of 21 years with the following diagnosis for whom informed consent can be obtained will be offered to be included in the trial.

Latent tuberculosis
Culture confirmed Tuberculosis
Clinically suspected Tuberculosis

Exclusion criteria

Any patient over 21
Any child or adult/guardian unable to give informed consent
Any persons under detention will not be included.
Any patient who is unable to give a sample.

Treatment and study plan

Culture and identify Mycobacterium tuberculosis from patient faeces

Diagnostic Test

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.

Other names: Diagnostic, Culture

Primary outcomes

To quantitate the speed of new culture method (TiKa) and compare its efficacy with conventional systems in detecting Mycobacterium tuberculosis in the faeces of paediatric patients with tuberculosis.

Time frame: 2 years

Samples will only include faeces (up to 10g) obtained once from outpatients and up to once per day for in-patients.

Faecal samples will be collected and placed into a routine sterile stool collection kit, labelled with a unique identifier allocated from its associated CRF and safe transport arranged to deliver the specimen to the research laboratory. On arrival all samples will be logged and a record kept in a secure locked site by a member of the research team.

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Acronym: TiKa-PAEDTB

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Apr 25, 2025
Registry last updated: Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed