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

NCT07448389 | Not Yet Recruiting

• 1 other identifier: CEC HCG 12-2025
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Leprosy; Costa Rica; Hansen's disease; Hansen

Outcome Measures

Primary Outcomes (3)

• Clinical Spectrum of Hansen Disease

  Proportion (%) of patients classified according to Ridley-Jopling clinical spectrum (tuberculoid, borderline tuberculoid, mid-borderline, borderline lepromatous, lepromatous) and operational classification (paucibacillary or multibacillary).

  2018-2025

• Frequency of Leprosy Reactions

  Proportion (%) of patients who developed type 1 reaction (reversal reaction) and type 2 reaction (erythema nodosum leprosum), including number of episodes per patient.

  2018-2025

• Disability Grade at Diagnosis

  Proportion (%) of patients with World Health Organization disability grade 0, 1, or 2 at diagnosis, based on neurological and ophthalmologic assessment documented in medical records.

  2018-2025

Secondary Outcomes (5)

• Peripheral Nerve Involvement

  2018-2025

• Bacteriological Index

  2018-2015

• Time to Diagnosis

  2018-2025

• Treatment Regimens and Duration

  2018-2025

• Use of Immunomodulatory Treatment for Reactions

  2018-2025

Eligibility Criteria

• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises all confirmed Hansen's disease cases registered in Costa Rica between 2018 and 2025 with available clinical records in public health institutions. This retrospective national census (\~108 cases) includes patients of any age and sex across endemic regions and care levels. Data derive from electronic health records and Ministry of Health surveillance databases, reflecting real-world epidemiologic distribution, clinical presentation, diagnostic practices, treatment, complications, disability, and outcomes in routine care without participant interaction.

You may qualify if:

• 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.

You may not qualify if:

• Cases whose diagnosis was reviewed and reclassified as another disease.

Sponsors & Collaborators

• Caja Costarricense de Seguro Social: lead

Study Sites (1)

Caja Costarricense del Seguro Social

San José, Provincia de San José, 40901, Costa Rica

Location

MeSH Terms

Conditions

Leprosy; Leprosy, Lepromatous; Leprosy, Multibacillary

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Daniel E Barquero-Orias, Dermatologist

CONTACT

+506 83411026; debarque@ccss.sa.cr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)