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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCaja Costarricense de Seguro Social

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of Hansen's disease.

Diagnosis between 1 January 2018 and 31 December 2025.

Any age or sex.

Available digital clinical record.

Disqualifiers

Cases whose diagnosis was reviewed and reclassified as another disease.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
2018-2025
2

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.

Time frame
2018-2025
3

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.

Time frame
2018-2025

Secondary outcomes

1

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.

Time frame
2018-2025
2

Bacteriological Index

Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.

Time frame
2018-2015
3

Time to Diagnosis

Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.

Time frame
2018-2025
4

Treatment Regimens and Duration

Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.

Time frame
2018-2025

Other outcomes

Sponsors and contacts

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