TuberculosisTiKa-PAEDTBNCT06944561
Improved Diagnostics for Paediatric Tuberculosis
A study testing Culture and identify Mycobacterium tuberculosis from patient faeces in people with Tuberculosis, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Improved diagnostics for paediatric Tuberculosis Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Culture and identify Mycobacterium tuberculosis from patient faeces
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2021to 2 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
CIU Office, St George's NHS Healthcare Trust
London
About this study
Improved diagnostics for paediatric Tuberculosis
Read the 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
- Conditions
- Tuberculosis
- Being tested
- Culture and identify Mycobacterium tuberculosis from patient faeces
- Keywords
- paediatric, Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture and identify Mycobacterium tuberculosis from patient faecesDiagnostic test
Also called Diagnostic, Culture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.
* Latent tuberculosis
* Culture confirmed Tuberculosis
* Clinically suspected Tuberculosis Receives: Diagnostic Test: Culture and identify Mycobacterium tuberculosis from patient faeces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start4 Oct 2021
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944561
- Sponsor's protocol ID
- JRES: 2020.0261
- Acronym
- TiKa-PAEDTB
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnostics for Paediatric Tuberculosis
- ClinicalTrials.gov ID
- NCT06944561
- Acronym / sponsor ID
- TiKa-PAEDTB / JRES: 2020.0261
- Conditions
- Tuberculosis
- Keywords
- paediatric, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric participants in the trial | Experimental | Diagnostic Test: Culture and identify Mycobacterium tuberculosis from patient faecesAny 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 |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culture and identify Mycobacterium tuberculosis from patient faecesAlso: Diagnostic, CultureWhen 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. | Diagnostic test | Paediatric participants in the trial |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culture and identify Mycobacterium tuberculosis from patient faeces in people with Tuberculosis, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.