Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Hansen's Disease in Costa Rica (2018-2025)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Leprosy, Hansen's Disease, Leprosy--Patients, Lepromatous Leprosy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Costa Rica
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Retrospective Observational Study for the Epidemiological, Clinical, Diagnostic, and Therapeutic Characterization of Hansen's Disease With Confirmed Diagnosis in Costa Rica During 2018-2025
Overview
The goal of this observational retrospective study is to characterize the epidemiologic, clinical, diagnostic, and therapeutic features of Hansen's disease cases in Costa Rica between 2018 and 2025. The main questions it aims to answer are: What are the epidemiologic and clinical characteristics of confirmed Hansen's disease cases in Costa Rica? What diagnostic methods, treatments, complications, and outcomes are observed in routine care? All confirmed Hansen's disease cases recorded in national surveillance and with available clinical records during 2018-2025 will be included. Data will be obtained from electronic health records and Ministry of Health reports without participant contact.
Detailed description
Hansen's disease remains a low-incidence but persistent infectious condition in Costa Rica, with ongoing transmission foci, diagnostic delays, and disability despite its elimination as a public health problem. Standard management relies on WHO-recommended multidrug therapy (rifampicin, dapsone, clofazimine) with adjunctive corticosteroids or thalidomide for reactions. Unlike interventional studies evaluating new drugs or preventive strategies, this investigation is a retrospective national characterization of all confirmed cases diagnosed between 2018 and 2025. It does not introduce therapeutic modifications or prospective follow-up, but instead analyzes real-world epidemiologic distribution, clinical manifestations, diagnostic methods (bacilloscopy, histology, molecular tests), classification, treatment patterns, complications, disability, cure, and relapse using existing records. By focusing on nationwide surveillance data and routine care outcomes, the study provides population-level evidence on Hansen's disease in a post-elimination setting, distinguishing it from clinical trials or cohort studies of specific interventions.
Primary outcome measures
- Clinical Spectrum of Hansen Disease [Time frame: 2018-2025]
- Frequency of Leprosy Reactions [Time frame: 2018-2025]
- Disability Grade at Diagnosis [Time frame: 2018-2025]
Secondary outcome measures (5)
- Peripheral Nerve Involvement [Time frame: 2018-2025]
- Bacteriological Index [Time frame: 2018-2015]
- Time to Diagnosis [Time frame: 2018-2025]
- Treatment Regimens and Duration [Time frame: 2018-2025]
- Use of Immunomodulatory Treatment for Reactions [Time frame: 2018-2025]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of Hansen's disease.
- Diagnosis between 1 January 2018 and 31 December 2025.
- Any age or sex.
- Available digital clinical record.
- Case reported in national surveillance (VE-01).
- Diagnosed or treated in Costa Rican public health institutions.
Exclusion criteria
- Cases whose diagnosis was reviewed and reclassified as another disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Costa Rica · 1 center
- Caja Costarricense del Seguro Social — San José
Identifiers
NCT: NCT07448389 · CEC HCG 12-2025