Improved Diagnostics for Paediatric Tuberculosis

NCT ID: NCT06944561

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2024-02-02

Brief Summary

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Improved diagnostics for paediatric Tuberculosis

Detailed Description

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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

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Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Paediatric participants in the trial

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

Group Type EXPERIMENTAL

Culture and identify Mycobacterium tuberculosis from patient faeces

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Diagnostic Culture

Eligibility Criteria

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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.
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CIU Office, St George's NHS Healthcare Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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JRES: 2020.0261

Identifier Type: -

Identifier Source: org_study_id

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