AgeingIGRageNCT01895582
Performance of IGRAs for TB Infection Diagnosis in Elderly
An observational study of Ageing and Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context. TB-infection diagnosis based on immunological memory detection can be impaired with age. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Ageing, Tuberculosis
- What is being tested?
- Blood samples
- How many people
- 160 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Jul 2013to 17 Mar 2019
- Phase
- Observational
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with suspected tuberculosis disease
Who may be able to join
- Age > 75 years
- Consent signed
- hospitalized patient with start treatment of Tuberculosis disease
- French social right
Who cannot join
- Tuberculosis disease treatment since 7 days
- No 3 months follow-up possible
- Immunosuppression
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de médecine interne
Bondy, 93143
Servive de Médecine Interne (Pr S. Herson)
Paris, 75013
Service de Médecine Interne, Diabete et Maladies Métaboliques
Strasbourg, 67000
About this study
Official title: Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.
TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.
Read the detailed description
In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis.
Principal outcome:
- 3 tests performance for active TB diagnosis in patients older than 75 years-old
Secondary outcomes :
- concordance between IGRAs.
- non-concordant results analysis
- concordance of IGRAs results with time of TB-infection
- biobank
Methodology :Diagnostic test performance study
- Conditions
- Ageing, Tuberculosis
- Being tested
- Blood samples
- Keywords
- Ageing, Tuberculosis, Interferon gamma releasing tests
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)
1 blood dry tube (5ml)
| Study group | Role | What they receive |
|---|---|---|
| Active TB-infected patients | TB-infected patients with bacteriological and histological evidences Receives: Other: Blood samples | |
| Non active TB-infected patients (already met TB) | some of elders have already met M tuberculosis before active antibiotherapy exists Receives: Other: Blood samples | |
| Non active TB-infected patients (other diagnosis) | same symptoms than two others groups but an other diagnosis Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of positive, indeterminate, negative tests in each group
Measured: month27
Secondary outcomes (4)
Test results in clinical LTBI patients
Measured: month 27
Correlation with TB-infection date
Test results (positive/negative) according to LTBI date
Measured: month 27
Blood samples collection in order to test new hypothesis in patients with non-concordant results
Measured: month 27
Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)
Measured: month 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start17 Jul 2013
- Primary completion17 Mar 2019
- Study completion17 Mar 2019
Why it stopped: lack of recruitment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guislaine CARCELAIN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895582
- Sponsor's protocol ID
- P110131
- Other IDs
- 2012-A00326-37
- Acronym
- IGRage
- Status last verified
- May 2021
- First submitted
- 27 Jun 2013
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)
- ClinicalTrials.gov ID
- NCT01895582
- Acronym / sponsor ID
- IGRage / P110131
- Conditions
- Ageing, Tuberculosis
- Keywords
- Ageing, Tuberculosis, Interferon gamma releasing tests
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitment of participants
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jul 2013 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 17 Mar 2019 (actual)
- First posted
- 10 Jul 2013 (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.
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.
TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.
Detailed description
In vitro Interferon Gamma releasing Assay (IGRA) are recommended for LTBI screening as or instead of TST, but there accuracy in those old patients are not known: as immune responses are impaired in elderly and some of them have already met M tuberculosis before active antibiotherapy exists.The aim of this study is to evaluate characteristics of the two commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in tube® and TST in old patients with or without active Tuberculosis.
Principal outcome:
- 3 tests performance for active TB diagnosis in patients older than 75 years-old
Secondary outcomes :
- concordance between IGRAs.
- non-concordant results analysis
- concordance of IGRAs results with time of TB-infection
- biobank
Methodology :Diagnostic test performance study
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active TB-infected patients | – | Other: Blood samplesTB-infected patients with bacteriological and histological evidences |
| Non active TB-infected patients (already met TB) | – | Other: Blood samplessome of elders have already met M tuberculosis before active antibiotherapy exists |
| Non active TB-infected patients (other diagnosis) | – | Other: Blood samplessame symptoms than two others groups but an other diagnosis |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with suspected tuberculosis disease
Key inclusion criteria (4 listed)
- Age > 75 years
- Consent signed
- hospitalized patient with start treatment of Tuberculosis disease
- French social right
Key exclusion criteria (3 listed)
- Tuberculosis disease treatment since 7 days
- No 3 months follow-up possible
- Immunosuppression
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 samples4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml) 1 blood dry tube (5ml) | Other | Active TB-infected patients, Non active TB-infected patients (already met TB), Non active TB-infected patients (other diagnosis) |
Primary outcome
Number of positive, indeterminate, negative tests in each group
Time frame: month27
4 secondary outcomes
Test results in clinical LTBI patients
Time frame: month 27
Correlation with TB-infection date
Time frame: month 27
Blood samples collection in order to test new hypothesis in patients with non-concordant results
Time frame: month 27
Performance comparison between tests (T-SPOT.TB®, Quantiferon-Gold-IT®)
Time frame: month 27
Results and safety
The study was stopped early (reason given: lack of recruitment of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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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.
Guislaine CARCELAIN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ageing and Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 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: stopped early, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 was stopped early (reason given: lack of recruitment of participants). Results are not available in the source record.
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?
Number of positive, indeterminate, negative tests in each group (time frame: month27). 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 28 May 2021.