Improved Diagnostics for Paediatric Tuberculosis (TiKa-PAEDTB)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- CIU Office, St George's NHS Healthcare Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
Time Frame: 2 years
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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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JRES: 2020.0261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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