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Improved diagnostics for paediatric Tuberculosis
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIU Office, St George's NHS Healthcare Trust | London | United Kingdom |
Analysed final data for release and publication will be retained and shared according to SGUL data management policy (http://www.sgul.ac.uk/images/about/Policies/SGUL\_RDM\_Policy\_May\_2016.pdf) within the SGUL data management repository. This data will not include personal identifiers and will pose no risk to ethical considerations.
The scope and nature of the data for processing will include. 1. Paediatric patient clinical history including age, sex and results of any routine investigations related to obtaining a diagnosis of tuberculosis. 2. Sample description, sample positivity (isolation of Mycobacterium tuberculosis achieved), sample infectious load and time to positivity. All data will be kept for 5 years post study termination/end.
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D003933 | Diagnosis |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |