Improved Diagnostics for Paediatric Tuberculosis (TiKa-PAEDTB)

St George's, University of London

Status: Completed

Conditions: Tuberculosis

Treatments: Diagnostic Test: Culture and identify Mycobacterium tuberculosis from patient faeces

Study type: Interventional

Funder types: Other

Identifiers

NCT06944561

JRES: 2020.0261

Details and patient eligibility

About

Improved diagnostics for paediatric Tuberculosis

Full 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

Enrollment: 16 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Paediatric participants in the trial

Experimental group

Description:

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

Treatment:

Diagnostic Test: Culture and identify Mycobacterium tuberculosis from patient faeces