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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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.
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.
Secondary outcomes
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.
Bacteriological Index
Continuous bacteriological index values obtained from slit-skin smear microscopy, when available.
Time to Diagnosis
Time interval in months between onset of symptoms and confirmed diagnosis of Hansen disease.
Treatment Regimens and Duration
Type of multidrug therapy regimen received (paucibacillary or multibacillary regimen) and total duration of treatment in months.
Sponsors and contacts
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