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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leprosy; Hansen's Disease; Leprosy Neuropathy; Lepromatous Leprosy; Leprosy, Multibacillary; Leprosy--Patients

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.

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Daniel E Barquero-Orias, Dermatologist; Phone Number: +506 83411026; Email: debarque@ccss.sa.cr

Study Locations

• Costa Rica
  • Provincia de San José
    • San José, Provincia de San José, Costa Rica, 40901
      • Caja Costarricense del Seguro Social
      • Contact: Daniel E Barquero-Orias, Dermatologist; Phone Number: +506 83411026; Email: debarque@ccss.sa.cr
      • Principal Investigator: Daniel E Barquero-Orias, Dermatologist
      • Sub-Investigator: Ana L Rivera-Chavarria, Medical Doctor
      • Sub-Investigator: Andres S Romero-Polini, Internist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Nerve Involvement	Frequency 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.	2018-2025
Bacteriological Index	Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.	2018-2015
Time to Diagnosis	Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.	2018-2025
Treatment Regimens and Duration	Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.	2018-2025
Use of Immunomodulatory Treatment for Reactions	Proportion (%) of patients requiring systemic corticosteroids, thalidomide, or other immunomodulatory agents for management of leprosy reactions.	2018-2025

Collaborators and Investigators

• Sponsor: Caja Costarricense de Seguro Social

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Leprosy; Costa Rica; Hansen's disease; Hansen
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Leprosy; Leprosy, Multibacillary; Leprosy, Lepromatous
• Other Study ID Numbers: CEC HCG 12-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No