Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 11:37 AM
Study NCT ID:
NCT04002869
Status:
UNKNOWN
Last Update Posted:
2021-02-03
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovation in Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': '01/01/2019 to 31/12/2022', 'description': 'Sensitivity, Specificity and predictive values'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Tuberculosis (TB) is one of the major infectious diseases worldwide, and the emergence and spread of drug resistant cases is a public health threat. However, the conventional methods used for diagnosis and drug-susceptibility testing are not enough for controlling the disease. In addition, all TB patients, independently of their age, gender, severity of the disease and type of responsible strain, follow the same treatment duration (up to 20 months in drug resistant cases), which often leads to high frequency of adverse events, suboptimal adherence to treatment, and poor outcome. Therefore, a transition from programmatic to personalized management of TB is needed.\n\nINNOVA4TB proposal will develop innovative technologies and approaches in order to improve the individual risk assessment for TB development, to rapidly diagnose active TB, to detect the drug susceptibility of the strain, to design tailor-made therapies, and to use biomarkers to guide and individualize the duration of antimicrobial therapy. This is of great importance for improving the quality of life of patients and ensuring treatment success, as well as for economic reasons for the healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Briefly, subjects from different study groups will be included: (i) patients with suspicion of active TB, (ii) individuals with latent TB infection, (iii) patients with NTM infection, (iv) healthy uninfected controls, and (v) patients with other respiratory diseases such as Acute Respiratory Infections (ARIs) or lung cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immunosuppression will not be considered an exclusion criterion\n\nExclusion Criteria:\n\n* Patients who are not able to give their informed consent to participate in the study will be excluded'}, 'identificationModule': {'nctId': 'NCT04002869', 'acronym': 'INNOVA4TB', 'briefTitle': 'Innovation in Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'Fundació Institut Germans Trias i Pujol'}, 'officialTitle': 'Innovation in Tuberculosis', 'orgStudyIdInfo': {'id': '823854'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active TB suspicion', 'description': "This study will include both adults and children with suspicion of different degrees of severity of active TB (pulmonary and extrapulmonary) to bring the investigator's study population into line with the routine clinical practice and to avoid the spectrum bias", 'interventionNames': ['Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic']}, {'label': 'Latent TB infection', 'description': 'Individuals with latent TB infection (adults and children), with positive TST and/or IGRAs; without any sign or radiological evidence of TB disease or any clinical picture compatible with the criteria defined in the section TB cases.', 'interventionNames': ['Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic']}, {'label': 'NTM infection', 'description': 'Adult and pediatric patients with lymphadenopathies caused by NTMs or individuals with chronic respiratory diseases with a NTM microbiologically confirmed by culture isolation.', 'interventionNames': ['Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic']}, {'label': 'Uninfected control', 'description': 'Both adult and children without active TB and no immunologic evidence of M. tuberculosis infection, with negative TST and/or IGRAs', 'interventionNames': ['Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic']}, {'label': 'Other respiratory diseases', 'description': 'Subjects with ARIs, and subjects with lung cancer; without any clinical picture compatible with the criteria defined in TB cases section. Patients with ARIs will be identified as individuals with clinical signs, symptoms and radiology of respiratory infections, and microbiological confirmation of non-TB origin. Patients with lung cancer will be identified as those with a high clinical suspicion, a suggestive chest X-ray/computed tomography scan, and a confirmed histopathological/cytological diagnosis', 'interventionNames': ['Diagnostic Test: Immunologic, molecular, metabolomic and radiolologic diagnostic']}], 'interventions': [{'name': 'Immunologic, molecular, metabolomic and radiolologic diagnostic', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluation and development of new technologies', 'armGroupLabels': ['Active TB suspicion', 'Latent TB infection', 'NTM infection', 'Other respiratory diseases', 'Uninfected control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'JOSE A DOMINGUEZ BENITEZ, PhD', 'role': 'CONTACT', 'email': 'jadominguez@igtp.cat', 'phone': '34934978697', 'phoneExt': '8697'}, {'name': 'BARBARA MOLINA MOYA, PhD', 'role': 'CONTACT', 'email': 'innova4tb@igtp.cat', 'phone': '34 93 497 8682', 'phoneExt': '8682'}], 'facility': "Institut D'Investigació Germans Trias I Pujol", 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}], 'centralContacts': [{'name': 'JOSE A DOMINGUEZ BENITEZ, PhD', 'role': 'CONTACT', 'email': 'jadominguez@igtp.cat', 'phone': '34 93 497 86 97', 'phoneExt': '8697'}, {'name': 'BARBARA MOLINA MOYA, PhD', 'role': 'CONTACT', 'email': 'innova4tb@igtp.cat', 'phone': '34 93 497 86 82', 'phoneExt': '8682'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'the only possibility of sharing data it will be as anonymized data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundació Institut Germans Trias i Pujol', 'class': 'OTHER'}, 'collaborators': [{'name': 'Consorcio Centro de Investigación Biomédica en Red (CIBER)', 'class': 'OTHER_GOV'}, {'name': 'Umeå University', 'class': 'OTHER'}, {'name': 'North-Western State Medical University named after I.I.Mechnikov', 'class': 'OTHER'}, {'name': 'INSTITUTUL DE FTIZIOPNEUMOLOGIE CHIRIL DRAGANIUC', 'class': 'UNKNOWN'}, {'name': 'ODESA SIGNIFICANT DISEASES CENTER', 'class': 'UNKNOWN'}, {'name': 'Vinnitsa National Medical University', 'class': 'OTHER'}, {'name': 'SERVICIOS CLINICOS SA', 'class': 'UNKNOWN'}, {'name': 'Genome Identification Diagnostics GmbH', 'class': 'UNKNOWN'}, {'name': 'EMPE DIAGNOSTICS AB', 'class': 'UNKNOWN'}, {'name': 'MAGRITEK GMBH', 'class': 'UNKNOWN'}, {'name': 'Universidad de La Frontera', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Jose Antonio Dominguez Benitez', 'investigatorAffiliation': 'Fundació Institut Germans Trias i Pujol'}}}}