Tuberculosis
Conditions
Keywords
paediatric, Tuberculosis
Brief summary
Improved diagnostics for paediatric Tuberculosis
Detailed 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
Interventions
DIAGNOSTIC_TESTCulture 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.
Sponsors
St George's, University of London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United Kingdom
Outcome results
None listed