Latent Tuberculosis InfectionPhase 4OPTIMISTNCT01223534
QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.
A Phase 4 study testing Preventive treatment with Isoniazid. and Preventive treatment with Isoniazid in people with Latent Tuberculosis Infection, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis cases among contacts screened. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- Preventive treatment with Isoniazid. and Preventive treatment with Isoniazid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 871 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to Feb 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Close contact of a pulmonary and/or laryngeal tuberculosis case.
- Written informed consent.
Who cannot join
- HIV infection.
- Immunosuppression other than HIV, such as decompensated liver disease, chronic renal failure, corticosteroids treatment, malignancy under chemotherapy therapy.
- Prior tuberculosis or positive TST.
- Strain resistant to Isoniazid (index case).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Bellvitge University Hospital, IDIBELL
L'Hospitalet de Llobregat, Barcelona, Barcelona, 08907
About this study
Official title: Comparison of Two Strategies for Therapeutic Decision-making in Tuberculosis Contact Tracing: a Standard Strategy Based on Tuberculin Skin Test (TST) Alone vs TST Combined With QuantiFERON®-TB Gold In-Tube (QFT-IT)
Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis cases among contacts screened.
Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing study.
Read more
Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.
Study population: 870 subjects, household contacts of patients with culture positive pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A (standard practice), in which treatment decisions will be based on the TST result, and Arm B (experimental), in which treatment decisions will be based on the QFT result.
Interventions: participants in arm A will undergo TST; participants in arm B will undergo TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be treated with isoniazid for 6 months. All participants will be followed for two years.
End-points of evaluation: development of tuberculosis and proportion of subjects for whom treatment is prescribed in each arm.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- Preventive treatment with Isoniazid., Preventive treatment with Isoniazid
- Keywords
- Tuberculosis, Latent tuberculosis infection, Tuberculin skin test, Interferon-gamma release assays, Contact-tracing study
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive treatment with Isoniazid.Drug
If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.
Preventive treatment with IsoniazidDrug
If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm A, Standard practice, TST | Active comparator | Participants allocated to screening as stablished by current practice (TST) Receives: Drug: Preventive treatment with Isoniazid. |
| Arm B, Experimental, TST plus QFT-IT | Experimental | Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection. Receives: Drug: Preventive treatment with Isoniazid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of tuberculosis.
Measured: Assessment of primary end-point: 24 months after randomization.
Secondary outcomes (1)
Prescription of treatment.
Measured: The day 0 (visit 2) after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2016
- Study completionFeb 2016
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 Latent Tuberculosis InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Cellestis
- Responsible party
- Principal investigator, Miguel Santín Cerezales, Hospital Universitari de Bellvitge
- Investigators
- Miguel Santin, MD, Study director, Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223534
- Sponsor's protocol ID
- QFT-ECC-01
- Other IDs
- 2009-017430-49, TRA-126, 2009
- Acronym
- OPTIMIST
- Status last verified
- May 2016
- First submitted
- 18 Oct 2010
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Munoz L, Santin M, Alcaide F, Ruiz-Serrano MJ, Gijon P, Bermudez E, Dominguez-Castellano A, Navarro MD, Ramirez E, Perez-Escolano E, Lopez-Prieto MD, Gutierrez-Rodriguez J, Anibarro L, Calvino L, Trigo M, Cifuentes C, Garcia-Gasalla M, Payeras A, Gasch O, Espasa M, Aguero R, Ferrer D, Casas X, Gonzalez-Cuevas A, Garcia-Zamalloa A, Bikuna E, Lecuona M, Galindo R, Ramirez-Lapausa M, Carrillo R; OPTIMIST Study Team. QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial. Clin Infect Dis. 2018 Jan 18;66(3):396-403. doi: 10.1093/cid/cix745.
PubMed 29020191
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies for Therapeutic Decision-making in Tuberculosis Contact Tracing: a Standard Strategy Based on Tuberculin Skin Test (TST) Alone vs TST Combined With QuantiFERON®-TB Gold In-Tube (QFT-IT)
- ClinicalTrials.gov ID
- NCT01223534
- Acronym / sponsor ID
- OPTIMIST / QFT-ECC-01
- Conditions
- Latent Tuberculosis Infection
- Keywords
- Tuberculosis, Latent tuberculosis infection, Tuberculin skin test, Interferon-gamma release assays, Contact-tracing study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Cellestis
- Study start
- Jul 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Oct 2010 (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.
Hypothesis: a combined strategy of tuberculin skin test (TST) followed by QuantiFERON-TB Gold In-Tube (QFT-IT) to confirm positivity (tuberculosis infection,in contact-tracing study will allow avoiding unnecessary preventive treatment without increasing rates of tuberculosis cases among contacts screened.
Aim of the study: to compare a combined strategy of the TST and the QFT-IT with TST alone for the diagnosis of tuberculosis infection and for therapeutic decision in contact tracing study.
Design and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.
Study population: 870 subjects, household contacts of patients with culture positive pulmonary and/or laryngeal tuberculosis will be randomized to one of two strategies: Arm A (standard practice), in which treatment decisions will be based on the TST result, and Arm B (experimental), in which treatment decisions will be based on the QFT result.
Interventions: participants in arm A will undergo TST; participants in arm B will undergo TST, and, in case of a positive result, QFT-IT as well. Participants with positive TST (arm A) and positive QFT-IT (arm B) will be diagnosed with tuberculosis infection and will be treated with isoniazid for 6 months. All participants will be followed for two years.
End-points of evaluation: development of tuberculosis and proportion of subjects for whom treatment is prescribed in each arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A, Standard practice, TST | Active comparator | Drug: Preventive treatment with Isoniazid.Participants allocated to screening as stablished by current practice (TST) |
| Arm B, Experimental, TST plus QFT-IT | Experimental | Drug: Preventive treatment with IsoniazidParticipants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Close contact of a pulmonary and/or laryngeal tuberculosis case.
- Written informed consent.
Key exclusion criteria (4 listed)
- HIV infection.
- Immunosuppression other than HIV, such as decompensated liver disease, chronic renal failure, corticosteroids treatment, malignancy under chemotherapy therapy.
- Prior tuberculosis or positive TST.
- Strain resistant to Isoniazid (index case).
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 |
|---|---|---|
| Preventive treatment with Isoniazid.If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months. | Drug | Arm A, Standard practice, TST |
| Preventive treatment with IsoniazidIf QFT-IT positive, Isoniazid 300 mg/d, for 6 months. | Drug | Arm B, Experimental, TST plus QFT-IT |
Primary outcome
Development of tuberculosis.
Time frame: Assessment of primary end-point: 24 months after randomization.
1 secondary outcome
Prescription of treatment.
Time frame: The day 0 (visit 2) after randomization.
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 27 May 2016.
- Derived from this study: PubMed 29020191Munoz L, Santin M, Alcaide F, Ruiz-Serrano MJ, Gijon P, Bermudez E, Dominguez-Castellano A, Navarro MD, Ramirez E, Perez-Escolano E, Lopez-Prieto MD, Gutierrez-Rodriguez J, Anibarro L, Calvino L, Trigo M, Cifuentes C, Garcia-Gasalla M, Payeras A, Gasch O, Espasa M, Aguero R, Ferrer D, Casas X, Gonzalez-Cuevas A, Garcia-Zamalloa A, Bikuna E, Lecuona M, Galindo R, Ramirez-Lapausa M, Carrillo R; OPTIMIST Study Team. QuantiFERON-TB Gold In-Tube as a Confirmatory Test for Tuberculin Skin Test in Tuberculosis Contact Tracing: A Noninferiority Clinical Trial. Clin Infect Dis. 2018 Jan 18;66(3):396-403. doi: 10.1093/cid/cix745.
- 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.
Miguel Santin, MD study director
Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)
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 Preventive treatment with Isoniazid. and Preventive treatment with Isoniazid in people with Latent Tuberculosis Infection, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 3 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 27 May 2016. 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 Spain. 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?
Development of tuberculosis. (time frame: Assessment of primary end-point: 24 months after randomization.). 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 NCT01223534, 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 27 May 2016.