Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-27 @ 5:47 PM
Study NCT ID:
NCT06761469
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leprosy Active Searching Trial in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007918', 'term': 'Leprosy'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Data analyst (statistician)'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Cluster stepped-wedge'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1925}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-05', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New cases of leprosy', 'timeFrame': 'From the date of identification of at least one positive response in the Leprosy Suspicion Questionnaire until the date of confirmation or ruling out leprosy, assessed up to 2 months.', 'description': 'Number of new cases of leprosy: incidence rate of leprosy per 100,000 inhabitants.'}], 'secondaryOutcomes': [{'measure': 'Leprosy Suspicion Questionnaire usefulness', 'timeFrame': 'From the application date of the Leprosy Suspicion Questionnaire and the rapid test until the date of confirmation or ruling out leprosy, it is assessed for up to 2 months.', 'description': 'Estimation of the diagnostic utility of positive LSQ and positive LSQ plus rapid test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leprosy', 'Active-case finding', 'Cluster stepped-wedge', 'Clinical trial', 'Brazil'], 'conditions': ['Leprosy']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:\n\n\\- Does the intervention increase the number of new leprosy cases detected compared to standard care?\n\nParticipants will:\n\n* Receive community awareness about leprosy.\n* Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.\n* Undergo clinical evaluation by a trained medical team.\n* If leprosy is diagnosed, affected patients will collect complementary laboratory exams\n\nHealthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of patients who have been diagnosed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n(I) Municipalities\n\n* Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.\n* Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.\n* Municipality with authorization/consent from the government to participate in the study.\n\n(II) Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.\n\n(III) Participants\n\n• Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents/guardians, 5-17 years old with ICF signed by parents/guardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.\n\nExclusion Criteria:\n\n(I) Municipalities\n\n* Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).\n* Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.\n* Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.\n\n(II) Primary Health Units\n\n* UBS with limited multidisciplinary team (absence of physicians, nurse and/or community health agents).\n* UBS with difficult access (no access by land, i.e. riverside populations).\n* UBS with territorial coverage exclusively of indigenous populations.\n\n(III) Participants\n\n* LSQ negative.\n* Patients with a previous diagnosis or history of treated leprosy.\n* Patients residing/registered outside the selected municipality."}, 'identificationModule': {'nctId': 'NCT06761469', 'acronym': 'LAST•Br', 'briefTitle': 'Leprosy Active Searching Trial in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Alemão Oswaldo Cruz'}, 'officialTitle': 'Pragmatic, Randomized, Cluster Stepped-Wedge Clinical Trial for Active Case Finding of Leprosy in Brazil', 'orgStudyIdInfo': {'id': '78510724.3.0000.0070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multifaceted intervention', 'description': 'Implementation of active-case finding strategies', 'interventionNames': ['Other: Implementing active-case finding strategies']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Routine screening'}], 'interventions': [{'name': 'Implementing active-case finding strategies', 'type': 'OTHER', 'description': 'Implementation of a multifactorial active-case finding strategy, including: (1) raising awareness among the population about leprosy; (2) theoretical and practical educational training for healthcare workers; (3) georeferencing of historical and existing cases in the municipality (from 2012 to 2023) and of new cases diagnosed throughout the study (dynamic changes); (4) screening tools for signs/symptoms of the disease (application of Leprosy Suspicion Questionnaire); and (5) serological profile (rapid test) of patients with reported signs/symptoms (positive answers Leprosy Suspicion Questionnaire).', 'armGroupLabels': ['Multifaceted intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01327-001', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Katia C Braz', 'role': 'CONTACT', 'email': 'katia.braz@haoc.com.br', 'phone': '+55 11 99616 5496'}, {'name': 'Gisele S Belber', 'role': 'CONTACT', 'email': 'gisele.belber@haoc.com.br', 'phone': '+55 11 94968 8725'}, {'name': 'Sebastian A Vernal, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Alemão Oswaldo Cruz', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Sebastian A Vernal, MD, PhD', 'role': 'CONTACT', 'email': 'vernal.carranza@gmail.com', 'phone': '+61 488 062 931'}, {'name': 'Katia C Braz', 'role': 'CONTACT', 'email': 'katia.braz@haoc.com.br', 'phone': '+55 11 99616 5496'}], 'overallOfficials': [{'name': 'Rosa C Lucchetta, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Alemão Oswaldo Cruz'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Alemão Oswaldo Cruz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Sebastian Andres Vernal Carranza', 'investigatorAffiliation': 'Hospital Alemão Oswaldo Cruz'}}}}