TuberculosisPhase 4QUANTIPSNCT00797836
Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers
A Phase 4 study testing Quantiferon Gold in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Quantiferon Gold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Nov 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group 1:
- Healthcare worker volunteering for the study
- Stable (expected employment in the unit > one year)
- Working in a high-risk units for tuberculosis (at least 5 cases of smear-positive pulmonary tuberculosis per year)
- Group 2 :
- Healthcare worker volunteering for the study
- With an unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient)
Who cannot join
- No informed consent
- Age < 18 years
- Employment in this unit < one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers
The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)
Read the detailed description
The QUANTIPS study includes two components:
- survey of HCWs working in high-risk units (respiratory diseases or infectious diseases with at least 5 case of smear-positive pulmonary tuberculosis par year) from 14 University hospitals in France
- Follow-up of HCWs with unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient) in 4 University hospitals Main objective: Therapeutic impact of tuberculosis screening using TST compared to QFTG. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone
Secondary objectives:
- Cost-effectiveness of replacing TST by QFTG
- Prevalence and incidence of latent tuberculosis in exposed HCWs (Part 1)
- Incidence of latent tuberculosis in HCWs exposed to an index case (part 2) Inclusion: HCWs who volunteer to participate in units with at least 5 patients with smear-positive tuberculosis each year (Group 1), HCWs exposed to a smear-positive patient non isolated at hospital admission (Group 2) Study population: 2000 (Group 1) and 600 (Group 2) HCWs Study duration: inclusion during 3 months, follow-up of one year (Group 1 ); Inclusion for one year, with a 3-month follow up (Group 2)
Study exams:
- Group 1 : TST, QFTG, chest radiography at baseline and after one year
- Group 2 : TST, QFTG, chest radiography at baseline (within 3 weeks after exposure) and after 3 months
Endpoints:
- therapeutic decision regarding tuberculosis treatment, with a cost-effectiveness analysis (Markov's modelling)
- prevalence and incidence of latent tuberculosis
- Conditions
- Tuberculosis
- Being tested
- Quantiferon Gold
- Keywords
- Occupational Diseases, Tuberculosis, Tuberculin Test, Immunoassay
- Medical subject headings
- Tuberculosis, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantiferon GoldProcedure or surgery
Also called Interferon-gama, evaluating tuberculosis-specific T-lymphocytic response
Interferon-gama release assay evaluating tuberculosis-specific T-lymphocytic response
Health Personnel Hospitals, General Occupational Diseases/*epidemiology/*statistics \& numerical data Occupational Exposure/*statistics \& numerical data
Tuberculosis/*diagnosis/*epidemiology/prevention \& control Immunologic Tests/methods/*standards Disease Transmission, Horizontal/*statistics \& numerical data Patient Isolation
Tuberculin Test/standards/*methods Immunoassay/methods/*standards T-Lymphocytes/immunology Interferon Type II/*blood/*analysis
*Reagent Kits, Diagnostic
Mass Screening/*methods Incidence Follow-Up Studies Comparative Study Sensitivity and Specificity Risk Assessment/*methods
| Study group | Role | What they receive |
|---|---|---|
| Quantiferon Gold | Experimental | Not described Receives: Procedure: Quantiferon Gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic impact of tuberculosis screening using QFTG compared to TST. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone
Measured: 18 months
Secondary outcomes (3)
Cost-effectiveness of replacing TST by QFTG
Measured: 18 months
Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)
Measured: 18 months
Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guislaine CARCELAIN, Dr, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797836
- Sponsor's protocol ID
- P070312
- Other IDs
- STIC AOM04013
- Acronym
- QUANTIPS
- Status last verified
- Nov 2008
- First submitted
- 24 Nov 2008
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-gamma release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: a longitudinal multicenter comparative study. Infect Control Hosp Epidemiol. 2015 May;36(5):569-74. doi: 10.1017/ice.2015.19. Epub 2015 Feb 16.
PubMed 25682769
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers
- ClinicalTrials.gov ID
- NCT00797836
- Acronym / sponsor ID
- QUANTIPS / P070312
- Conditions
- Tuberculosis
- Keywords
- Occupational Diseases, Tuberculosis, Tuberculin Test, Immunoassay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 25 Nov 2008 (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.
The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)
Detailed description
The QUANTIPS study includes two components:
- survey of HCWs working in high-risk units (respiratory diseases or infectious diseases with at least 5 case of smear-positive pulmonary tuberculosis par year) from 14 University hospitals in France
- Follow-up of HCWs with unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient) in 4 University hospitals Main objective: Therapeutic impact of tuberculosis screening using TST compared to QFTG. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone
Secondary objectives:
- Cost-effectiveness of replacing TST by QFTG
- Prevalence and incidence of latent tuberculosis in exposed HCWs (Part 1)
- Incidence of latent tuberculosis in HCWs exposed to an index case (part 2) Inclusion: HCWs who volunteer to participate in units with at least 5 patients with smear-positive tuberculosis each year (Group 1), HCWs exposed to a smear-positive patient non isolated at hospital admission (Group 2) Study population: 2000 (Group 1) and 600 (Group 2) HCWs Study duration: inclusion during 3 months, follow-up of one year (Group 1 ); Inclusion for one year, with a 3-month follow up (Group 2)
Study exams:
- Group 1 : TST, QFTG, chest radiography at baseline and after one year
- Group 2 : TST, QFTG, chest radiography at baseline (within 3 weeks after exposure) and after 3 months
Endpoints:
- therapeutic decision regarding tuberculosis treatment, with a cost-effectiveness analysis (Markov's modelling)
- prevalence and incidence of latent tuberculosis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quantiferon Gold | Experimental | Procedure: Quantiferon Gold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthcare worker volunteering for the study
- Stable (expected employment in the unit > one year)
- Working in a high-risk units for tuberculosis (at least 5 cases of smear-positive pulmonary tuberculosis per year)
- Healthcare worker volunteering for the study
- With an unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient)
Key exclusion criteria (3 listed)
- No informed consent
- Age < 18 years
- Employment in this unit < one year
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 |
|---|---|---|
| Quantiferon GoldAlso: Interferon-gama, evaluating tuberculosis-specific T-lymphocytic responseInterferon-gama release assay evaluating tuberculosis-specific T-lymphocytic response Health Personnel Hospitals, General Occupational Diseases/*epidemiology/*statistics \& numerical data Occupational Exposure/*statistics \& numerical data Tuberculosis/*diagnosis/*epidemiology/prevention \& control Immunologic Tests/methods/*standards Disease Transmission, Horizontal/*statistics \& numerical data Patient Isolation Tuberculin Test/standards/*methods Immunoassay/methods/*standards T-Lymphocytes/immunology Interferon Type II/*blood/*analysis *Reagent Kits, Diagnostic Mass Screening/*methods Incidence Follow-Up Studies Comparative Study Sensitivity and Specificity Risk Assessment/*methods | Procedure or surgery | Quantiferon Gold |
Primary outcome
Therapeutic impact of tuberculosis screening using QFTG compared to TST. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone
Time frame: 18 months
3 secondary outcomes
Cost-effectiveness of replacing TST by QFTG
Time frame: 18 months
Prevalence and incidence of latent tuberculosis in exposed HCWs (Group 1)
Time frame: 18 months
Incidence of latent tuberculosis in HCWs exposed to an index case (Group 2)
Time frame: 18 months
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 10 Jan 2012.
- Derived from this study: PubMed 25682769Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-gamma release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: a longitudinal multicenter comparative study. Infect Control Hosp Epidemiol. 2015 May;36(5):569-74. doi: 10.1017/ice.2015.19. Epub 2015 Feb 16.
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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, Dr study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quantiferon Gold in people with Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 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 10 Jan 2012. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Therapeutic impact of tuberculosis screening using QFTG compared to TST. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797836, which also lists 1 linked publication.
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 10 Jan 2012.