Clinical trial NCT06523998: A Study on Rare Dermatological Infections Conducted at Three Major Reference Hospitals in Costa Rica.
Official title: Retrospective Descriptive Observational Study of the Epidemiological, Clinical and Therapeutic Profile of Patients With Rare Infections of Dermatological Interest at Three Major Reference Hospitals in Costa Rica From 2019-2023
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sporotrichosis
Chromomycosis
Actinomycosis
Nocardiosis
Mycetoma
Mycobacterial Cutaneous Infection
Coccidioidomycosis
Blastomycosis
Paracoccidioidomycosis
Phaeomycosis
Keywords: Bacterial Infections and Mycoses
Infectious Skin Diseases
Sporotrichosis
Chromoblastomycosis
Mycetoma
Non-tuberculous mycobacteria
Lead sponsor: Caja Costarricense de Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-07-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years with confirmed microbiological, histological and/or molecular diagnosis of sporotrichosis, chromomycosis, actinomycosis, nocardiosis, mycetoma, mycobacterial infection, coccidioidomycosis, blastomycosis, paracoccidioidomycosis, cutaneous nocardiosis and pheomycotic abscess diagnosed and/or treated at Hospital México, Hospital Rafael Calderón Guardia, and Hospital San Juan de Dios during the period 2019-2023.

Brief summary: In Costa Rica there are some descriptive studies of some of these rare infectious diseases (sporotrichosis, chromomycosis and mycetomas); however, there are no recent published reports. Most of the publications on the subject date back to the previous century; from 2000 to the present year there are only publications of small series of cases, so the current behavior of these skin infections is unknown. The primary objective is to analyze the epidemiological, clinical, and therapeutic profile and determine the risk factors in patients with a diagnosis of rare infections of dermatological interest treated at Hospital México, Hospital Rafael Calderón Guardia, and Hospital San Juan de Dios during the period 2019-2023.


Eligibility criteria: Inclusion Criteria:

1. Age over 18 years, regardless of gender and ethnic group.
2. Patients who during the period from January 1, 2019 to December 31, 2023 received medical care at the Hospital Rafael Ángel Calderón Guardia, Hospital México and Hospital San Juan de Dios.
3. Subjects who meet a confirmed microbiological, histological and/or molecular diagnosis of sporotrichosis, chromomycosis, actinomycosis, nocardiosis, mycetoma, mycobacterial infection, coccidioidomycosis, blastomycosis, paracoccidioidomycosis, cutaneous nocardiosis and pheomycotic abscess (either through the unique digital health record, pathology registries, clinical laboratory service database of each hospital, clinical laboratory of the University of Costa Rica and Instituto Costarricense de Investigación y Enseñanza en Nutrición y Salud).
4. Subjects diagnosed at a private level and referred to continue medical care at Hospital Rafael Ángel Calderón Guardia, Hospital México and Hospital San Juan de Dios.

Exclusion Criteria:

1. The research team may exclude patients who have an unconfirmed diagnosis, an erroneous diagnosis, or have participated in the study before, as they may hinder the ability to obtain satisfactory data to achieve the study's objectives.
2. Patients who have more than 30% of the variables required for analysis missing will also be excluded from the study.

Primary outcomes:
measure: Analyze epidemiological, clinical, and therapeutic profile
timeFrame: 5 year
measure: Determine the risk factors
timeFrame: 5 year
measure: Determine the diagnostic methods
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Hospital Rafael Ángel Calderón Guardia
city: San José
country: Costa Rica
facility: Hospital San Juan de Dios
city: San José
country: Costa Rica
facility: Hospital México
Study officials:
affiliation: Caja Costarricense de Seguro Social
name: Daniel E Barquero Orias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bolognia JL, Schaffer JV, Cerroni L, Callen JP. Dermatología. 4th ed. Barcelona: Elsevier; 2019.
citation: Kang S, Amagai M, Bruckner AL, Enk AH, Margolis DJ, McMichael AJ, et al. Fitzpatrick's Dermatology. 9th ed. New York: McGraw-Hill Education; 2019.
citation: Trejos A. La cromoblastomicosis como problema micológico [Tesis de grado para optar por el título de licenciatura en Microbiología]. San José, Costa Rica: Universidad de Costa Rica, 1954.
citation: Trejos A. Cladosporium carrionii n. sp. and the problem of Cladosporia isolated from chromoblastomycosis. Rev Biol Trop. 1954, 2(1):75-112.
citation: Mora M, Molina B, Moya A. Cromoblastomicosis por Cladophialophora Carrionnii: Primer caso descrito en literatura costarricense. Rev. méd. Costa Rica Centroam. 2010;67(594):373-6.
citation: Romero A, Trejos A. La cromomicosis en Costa Rica. Rev Biol Trop. 1953;1(2):95-115.
citation: Soto L, Jaikel D. Cromoblastomicosis: Situación en Costa Rica. Rev. méd. Costa Rica Centroam. 2014;71(613):737-44.
citation: Salazar K. Esporotricosis y cromoblastomicosis en San Ramón de Costa Rica. Acta Med Costarr. 2022;64(3):1-5. Disponible en https://doi.org/10.51481/amc.v64i3.1224
citation: Solano E. Cromomicosis. Acta Med Costarr. 1966;9(2):77-85.
citation: Astorga E, Bonilla E, Martínez C, Mora W. Cromomicosis (Nuevos casos de Cromomicosis tratados con Anfotericina B y 5·Fluorcitosina en forma simultánea). Rev. Méd. de Costa Rica. 1980;47(479):17-22.
citation: Sáenz L, Morera P. Sobre un caso de blastomicosis suramericana asociada a cromomicosis. Acta Med Costarr. 1963;6(1):55-71.
citation: Alice E. Ecología de Sporothrix schenkii. Rev Méd de Costa Rica. 1982;49(479):81-6.
citation: Rodríguez J. Aspectos clínicos, epidemiológicos y ecológicos sobre 100 casos de Esporotricosis en Costa Rica. Revista costarricense de Ciencias Médicas. 1992;12:29-36.
citation: González J, Rodríguez J. Tres casos de Esporotricosis. Revista costarricense de Ciencias Médicas. 1990;12:57-9.
citation: Jaramillo O. Esporotricosis en Costa Rica: Estudio clínico epidemiológico y terapéutico de cien casos. Boletín Médico del Seguro Social de Costa Rica. 1972;1(4):27-37.
citation: Rodríguez J, Gamboa A, Alvarado F. Etiología y epidemiología de los micetomas en Costa Rica. Rev. iberoamer. micol. 1988;5:144-8.
citation: Trejos A, Romero A. Contribución al estudio de las blastomicosis en Costa Rica. Rev Biol Trop. 1953;1(1):63-81.
citation: Astorga E, Mora W, Rodríguez A. Tratamiento de la Paracoccidioidomicosis con Ketoconazol (Primer caso en Costa Rica). Rev. Méd. de Costa Rica. 1986;53(494):1-3.
citation: Fernández K, Quirós JL. Paracoccidiodomicosis: (Reporte de siete casos). Rev. méd. Costa Rica Centroam. 2008;65(582):41-7.
citation: Kawer A, Madrigal L, Mata F. Paracoccidioidomicosis en lengua. Rev. méd. Costa Rica Centroam. 2011;68(599):505-8.
citation: Bonilla E, Miranda M, Mata L. Reporte del primer caso de Nocardiasis en Costa Rica. Acta Med Costarr. 1960;3(1):51-5.
citation: Cueva A. Nocardiosis. Acta Med Costarr. 1968;11(1):45-51. 23.
citation: Castro A, Trejos A. Constatación del primer caso centroamericano de Coccidioidomicosis. Rev Biol Trop. 1953;83-93.
citation: Hidalgo W, Xinirachs H, Cappella E, Solano E. Un caso de actinomicosis cervicofacial por Actinomyces bovis. Rev Biol Trop. 1960;8(2):155-63.
citation: Hidalgo W, Morera P, Hernández VM, Suárez A, Céspedes R. Criptococosis Estudio del primer caso confirmado en Costa Rica. Acta Med Costarr. 1960;3(5):221-35.
citation: Brizuela S, Montero N. Criptococosis asociado a VIH/SIDA (A propósito de un paciente). Rev. méd. Costa Rica Centroam. 2013;70(605):43-7.
citation: Mora J, Salazar J, Calderón C, García R. Rinosporidiosis en Costa Rica. (Revisión del tema e informe del primer caso en nuestro país). Acta Med Costarr. 1985;28(2):122-5.
citation: Riggioni S, Díaz S. Lacaziosis: Micosis cutánea profunda, Reporte de un caso. Rev. clín. esc. med. UCR-HSJD. 2015 Jun 29;5(3). https://doi.org/10.15517/rc_ucr-hsjd.v5i3.19916