TuberculosisNextGenNCT02512939
Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection
A study testing blood test, not yet marketed, no trade name in people with Tuberculosis, run by University College, London at 5 sites in United Kingdom.
Trial summary
This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- blood test, not yet marketed, no trade name
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jul 2015to 30 Nov 2016
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Contacts: Adult (aged 16 years or older) contacts of smearpositive pulmonary TB patients attending participating TB clinics or primary care centres for screening will be invited to take part. Contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). Patients with active TB: Newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating TB clinics or primary care centres. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators.
Who cannot join
- Contacts: Active TB disease. Individuals who are unable to give informed consent. Children aged under 16 years.
- TB cases: Individuals who are unable to give informed consent. Children aged under 16 years.
- Hajj pilgrims: Active TB disease. Any health indication which would prevent travel to Saudi Arabia. Individuals who are unable to give informed consent. Children aged under 16 years.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Barts NHS Trust
London
Ealing Hospital
London
North Middlesex Hospital
London
Northwick Park Hospital
London
West Middlesex Hospital NHS Trust
London
About this study
This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.
Read the detailed description
Currently available blood tests for latent tuberculosis infection (LTBI) identify people who have been previously infected with M. tuberculosis. Whilst they are sensitive and specific, they cannot be used to monitor the effectiveness of treatment for LTBI. New blood tests ("fourth generation Quantiferon tests") give a more complete measurement of the workings of the immune system, which may be useful to show whether treatment is working. These new tests have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of TB disease and monitoring treatment is unknown.
Mass gatherings, such as the annual Hajj pilgrimage, may encourage the spread of infectious diseases, including respiratory infections such as influenza, respiratory syncytial virus, and possibly also tuberculosis. However, the risk of TB infection during the Hajj has not been reliably measured. It is important to measure this risk so that pilgrims can be given suitable advice about preventing infection.
- Conditions
- Tuberculosis
- Being tested
- blood test, not yet marketed, no trade name
- Keywords
- tuberculosis, diagnostic test
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood test, not yet marketed, no trade nameProcedure or surgery
blood test using the new TB diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Contacts of TB cases | Experimental | Blood test, not yet marketed, development phase Receives: Procedure: blood test, not yet marketed, no trade name |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess prognostic ability of blood test by assessing development of active TB disease compared to the current gold standard
assess prognostic ability of blood test by assessing development of active TB disease.
Measured: 1 year
Secondary outcomes (2)
assess the sensitivity of new blood tests for detecting TB infection in patients with active TB disease compared to teh current godl standard
estimate the sensitivity of new blood tests for detecting TB infection in patients with active TB disease
Measured: 1 year
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
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.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health England
- Responsible party
- Sponsor
- Investigators
- Ibrahim Abubakar, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512939
- Sponsor's protocol ID
- Next gen
- Acronym
- NextGen
- Status last verified
- May 2023
- First submitted
- 28 Jul 2015
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Values of Next Generation Interferon Gamma Release Assays for Latent Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT02512939
- Acronym / sponsor ID
- NextGen / Next gen
- Conditions
- Tuberculosis
- Keywords
- tuberculosis, diagnostic test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Public Health England
- Study start
- Jul 2015
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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.
This study will assess the next generation of blood tests for latent TB infection, which may be able to indicate how treatment is working as well as in diagnosis infection.
Detailed description
Currently available blood tests for latent tuberculosis infection (LTBI) identify people who have been previously infected with M. tuberculosis. Whilst they are sensitive and specific, they cannot be used to monitor the effectiveness of treatment for LTBI. New blood tests ("fourth generation Quantiferon tests") give a more complete measurement of the workings of the immune system, which may be useful to show whether treatment is working. These new tests have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of TB disease and monitoring treatment is unknown.
Mass gatherings, such as the annual Hajj pilgrimage, may encourage the spread of infectious diseases, including respiratory infections such as influenza, respiratory syncytial virus, and possibly also tuberculosis. However, the risk of TB infection during the Hajj has not been reliably measured. It is important to measure this risk so that pilgrims can be given suitable advice about preventing infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contacts of TB cases | Experimental | Procedure: blood test, not yet marketed, no trade nameBlood test, not yet marketed, development phase |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Contacts: Adult (aged 16 years or older) contacts of smearpositive pulmonary TB patients attending participating TB clinics or primary care centres for screening will be invited to take part. Contacts will include all individuals with a cumulative duration of exposure of greater than eight hours to the relevant index case in a confined space during the period of infectiousness (prior to initiation of treatment). Patients with active TB: Newly diagnosed, microbiologically confirmed tuberculosis disease (pulmonary or extrapulmonary) attending participating TB clinics or primary care centres. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators.
Key exclusion criteria (3 listed)
- Contacts: Active TB disease. Individuals who are unable to give informed consent. Children aged under 16 years.
- TB cases: Individuals who are unable to give informed consent. Children aged under 16 years.
- Hajj pilgrims: Active TB disease. Any health indication which would prevent travel to Saudi Arabia. Individuals who are unable to give informed consent. Children aged under 16 years.
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 |
|---|---|---|
| blood test, not yet marketed, no trade nameblood test using the new TB diagnostic test | Procedure or surgery | Contacts of TB cases |
Primary outcome
assess prognostic ability of blood test by assessing development of active TB disease compared to the current gold standard
Time frame: 1 year
assess prognostic ability of blood test by assessing development of active TB disease.
2 secondary outcomes
assess the sensitivity of new blood tests for detecting TB infection in patients with active TB disease compared to teh current godl standard
Time frame: 1 year
estimate the risk of infection with M. tuberculosis and other respiratory pathogens amongst UK pilgrims undertaking the Hajj.
Time frame: 1 year
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 16 May 2023.
- Individual participant dataSharing planned: No
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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.
Ibrahim Abubakar, PhD principal investigator
University College, London
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test, not yet marketed, no trade name in people with Tuberculosis, run by University College, London at 5 sites 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 1 inclusion and 3 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
assess prognostic ability of blood test by assessing development of active TB disease compared to the current gold standard (time frame: 1 year). 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 16 May 2023.