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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07448389
Enrollment
130
Registered
2026-03-04
Start date
2026-05-01
Completion date
2026-12-01
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Leprosy, Costa Rica, Hansen's disease, Hansen

Brief 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.

Interventions

None listed

Sponsors

Caja Costarricense de Seguro Social
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Spectrum of Hansen Disease2018-2025Proportion (%) of patients classified according to Ridley-Jopling clinical spectrum (tuberculoid, borderline tuberculoid, mid-borderline, borderline lepromatous, lepromatous) and operational classification (paucibacillary or multibacillary).
Frequency of Leprosy Reactions2018-2025Proportion (%) of patients who developed type 1 reaction (reversal reaction) and type 2 reaction (erythema nodosum leprosum), including number of episodes per patient.
Disability Grade at Diagnosis2018-2025Proportion (%) of patients with World Health Organization disability grade 0, 1, or 2 at diagnosis, based on neurological and ophthalmologic assessment documented in medical records.

Secondary

MeasureTime frameDescription
Peripheral Nerve Involvement2018-2025Frequency and distribution of clinically affected peripheral nerves (ulnar, median, radial, common peroneal, posterior tibial, and facial nerves), including presence of nerve enlargement, pain, or sensory/motor deficit.
Bacteriological Index2018-2015Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.
Time to Diagnosis2018-2025Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.
Treatment Regimens and Duration2018-2025Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.
Use of Immunomodulatory Treatment for Reactions2018-2025Proportion (%) of patients requiring systemic corticosteroids, thalidomide, or other immunomodulatory agents for management of leprosy reactions.

Countries

Costa Rica

Contacts

CONTACTDaniel E Barquero-Orias, Dermatologist
debarque@ccss.sa.cr+506 83411026

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026