NCT07448389

Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Hansen's Disease in Costa Rica (2018-2025)

Retrospective Observational Study for the Epidemiological, Clinical, Diagnostic, and Therapeutic Characterization of Hansen's Disease With Confirmed Diagnosis in Costa Rica During 2018-2025

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Caja Costarricense de Seguro Social · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Leprosy
• Hansen's Disease
• Leprosy--Patients
• Lepromatous Leprosy
• Leprosy, Multibacillary
• Leprosy Neuropathy

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-03-04
• Last updated: 2026-03-09

Locations

1 site across 1 country: Costa Rica