TIKA-PAEDTB: Improved diagnostics for Paediatric Tuberculosis

Open to recruitment

Aim of the study

To test the feasibility of TiKa system to reliably detect Mycobacterium tuberculosis in faeces of paediatric patients with Tuberculosis.

Inclusion criteria

Any patient under the age of 16 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 16
  • 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

The following data will be collected:

Samples will only include obtaining a sample of faeces (1g or greater) from 50 patients fulfilling the inclusion criteria and exclusion criteria for whom consent has been obtained.

Sampling is restricted to patients with a suspected or previously known Tuberculosis diagnosis to maximise the probability that samples will yield a positive culture. All patients will be required to provide at least one sample.
Patients will not be paid or offered renumeration for participation.

Parents/Guardians of potential participants will be approached by the routine clinical team and asked if they would be interested to participate. If they express an interest one of the clinical research team will contact them at that time or subsequently. If they fulfil the inclusion and not exclusion criteria and give consent then samples will be obtained, pseudo-anonymised by a member of the clinical team and given a sample identifier number that could only be referred back to the CRF which itself will contain no identifiable personal information (only available to the clinical research team and held as a separate log in a secure facility).