Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 2:24 PM
Study NCT ID:
NCT01223534
Status:
COMPLETED
Last Update Posted:
2016-05-27
First Post:
2010-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007538', 'term': 'Isoniazid'}], 'ancestors': [{'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 871}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-26', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of tuberculosis.', 'timeFrame': 'Assessment of primary end-point: 24 months after randomization.'}], 'secondaryOutcomes': [{'measure': 'Prescription of treatment.', 'timeFrame': 'The day 0 (visit 2) after randomization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Latent tuberculosis infection', 'Tuberculin skin test', 'Interferon-gamma release assays', 'Contact-tracing study'], 'conditions': ['Latent Tuberculosis Infection']}, 'referencesModule': {'references': [{'pmid': '29020191', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAim 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.\n\nDesign and setting: Prospective, multicentre, comparative study in 12 hospitals in Spain.\n\nStudy 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.\n\nInterventions: 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.\n\nEnd-points of evaluation: development of tuberculosis and proportion of subjects for whom treatment is prescribed in each arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Close contact of a pulmonary and/or laryngeal tuberculosis case.\n* Written informed consent.\n\nExclusion Criteria:\n\n* HIV infection.\n* Immunosuppression other than HIV, such as decompensated liver disease, chronic renal failure, corticosteroids treatment, malignancy under chemotherapy therapy.\n* Prior tuberculosis or positive TST.\n* Strain resistant to Isoniazid (index case).'}, 'identificationModule': {'nctId': 'NCT01223534', 'acronym': 'OPTIMIST', 'briefTitle': 'QuantiFERON®-TB Gold In-Tube for the Diagnosis of Tuberculosis Infection in Contact Tracing Study.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'QFT-ECC-01'}, 'secondaryIdInfos': [{'id': '2009-017430-49', 'type': 'EUDRACT_NUMBER'}, {'id': 'TRA-126', 'type': 'OTHER_GRANT', 'domain': 'Spanish Ministry of Health and Social Policy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A, Standard practice, TST', 'description': 'Participants allocated to screening as stablished by current practice (TST)', 'interventionNames': ['Drug: Preventive treatment with Isoniazid.']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B, Experimental, TST plus QFT-IT', 'description': 'Participants allocated to screening with TST, and if positive, followed by QFT-IT to confirm tuberculosis infection.', 'interventionNames': ['Drug: Preventive treatment with Isoniazid']}], 'interventions': [{'name': 'Preventive treatment with Isoniazid.', 'type': 'DRUG', 'description': 'If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.', 'armGroupLabels': ['Arm A, Standard practice, TST']}, {'name': 'Preventive treatment with Isoniazid', 'type': 'DRUG', 'description': 'If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.', 'armGroupLabels': ['Arm B, Experimental, TST plus QFT-IT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat, Barcelona", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Bellvitge University Hospital, IDIBELL'}], 'overallOfficials': [{'name': 'Miguel Santin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bellvitge University Hospital, Bellvitge Institute for Biomedical Research (IDIBELL)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cellestis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MD', 'investigatorFullName': 'Miguel Santín Cerezales', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}