Improved Diagnostics for Paediatric Tuberculosis

NCT06944561 | Completed DMC

• 1 other identifier: JRES: 2020.0261
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Improved diagnostics for paediatric Tuberculosis

Conditions

Tuberculosis

Keywords

paediatric; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  2 years

Study Arms (1)

Paediatric participants in the trial

EXPERIMENTAL

Any patient under the age of 21 years with the following diagnosis for whom informed consent could be obtained was offered to be included in the trial. * Latent tuberculosis * Culture confirmed Tuberculosis * Clinically suspected Tuberculosis

Diagnostic Test: Culture and identify Mycobacterium tuberculosis from patient faeces

Interventions

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.

Also known as: Diagnostic, Culture

Paediatric participants in the trial

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

CIU Office, St George's NHS Healthcare Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: April 25, 2025
• Study Start: October 4, 2021
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: April 25, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)