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临床试验/NCT07448389
NCT07448389
尚未招募
不适用

Retrospective Observational Study for the Epidemiological, Clinical, Diagnostic, and Therapeutic Characterization of Hansen's Disease With Confirmed Diagnosis in Costa Rica During 2018-2025

Caja Costarricense de Seguro Social1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2026年5月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
130
试验地点
1
主要终点
Clinical Spectrum of Hansen Disease

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of Hansen's disease.
  • Diagnosis between 1 January 2018 and 31 December
  • Any age or sex.
  • Available digital clinical record.
  • Case reported in national surveillance (VE-01).
  • Diagnosed or treated in Costa Rican public health institutions.

排除标准

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

结局指标

主要结局

Clinical Spectrum of Hansen Disease

时间窗: 2018-2025

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

时间窗: 2018-2025

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

时间窗: 2018-2025

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.

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Daniel Barquero Orias

Principal Investigator

Caja Costarricense de Seguro Social

研究点 (1)

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