- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06523998
A Study on Rare Dermatological Infections Conducted at Three Major Reference Hospitals in Costa Rica.
July 26, 2024 updated by: Daniel Barquero Orias, Caja Costarricense de Seguro Social
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
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
95
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San José, Costa Rica, 10101
- Hospital Rafael Ángel Calderón Guardia
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San José, Costa Rica, 10103
- Hospital San Juan de Dios
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San José, Costa Rica, 10107
- Hospital México
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- Age over 18 years, regardless of gender and ethnic group.
- 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.
- 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).
- 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:
- 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.
- Patients who have more than 30% of the variables required for analysis missing will also be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyze epidemiological, clinical, and therapeutic profile
Time Frame: 5 year
|
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.
|
5 year
|
|
Determine the risk factors
Time Frame: 5 year
|
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.
|
5 year
|
|
Determine the diagnostic methods
Time Frame: 5 year
|
Determine the diagnostic methods utilized for each case, including culture, histological techniques, and molecular testing.
|
5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel E Barquero Orias, MD, Caja Costarricense de Seguro Social
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bolognia JL, Schaffer JV, Cerroni L, Callen JP. Dermatología. 4th ed. Barcelona: Elsevier; 2019.
- 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.
- 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.
- Trejos A. Cladosporium carrionii n. sp. and the problem of Cladosporia isolated from chromoblastomycosis. Rev Biol Trop. 1954, 2(1):75-112.
- 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.
- Romero A, Trejos A. La cromomicosis en Costa Rica. Rev Biol Trop. 1953;1(2):95-115.
- Soto L, Jaikel D. Cromoblastomicosis: Situación en Costa Rica. Rev. méd. Costa Rica Centroam. 2014;71(613):737-44.
- 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
- Solano E. Cromomicosis. Acta Med Costarr. 1966;9(2):77-85.
- 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.
- Sáenz L, Morera P. Sobre un caso de blastomicosis suramericana asociada a cromomicosis. Acta Med Costarr. 1963;6(1):55-71.
- Alice E. Ecología de Sporothrix schenkii. Rev Méd de Costa Rica. 1982;49(479):81-6.
- Rodríguez J. Aspectos clínicos, epidemiológicos y ecológicos sobre 100 casos de Esporotricosis en Costa Rica. Revista costarricense de Ciencias Médicas. 1992;12:29-36.
- González J, Rodríguez J. Tres casos de Esporotricosis. Revista costarricense de Ciencias Médicas. 1990;12:57-9.
- 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.
- Rodríguez J, Gamboa A, Alvarado F. Etiología y epidemiología de los micetomas en Costa Rica. Rev. iberoamer. micol. 1988;5:144-8.
- Trejos A, Romero A. Contribución al estudio de las blastomicosis en Costa Rica. Rev Biol Trop. 1953;1(1):63-81.
- 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.
- Fernández K, Quirós JL. Paracoccidiodomicosis: (Reporte de siete casos). Rev. méd. Costa Rica Centroam. 2008;65(582):41-7.
- Kawer A, Madrigal L, Mata F. Paracoccidioidomicosis en lengua. Rev. méd. Costa Rica Centroam. 2011;68(599):505-8.
- Bonilla E, Miranda M, Mata L. Reporte del primer caso de Nocardiasis en Costa Rica. Acta Med Costarr. 1960;3(1):51-5.
- Cueva A. Nocardiosis. Acta Med Costarr. 1968;11(1):45-51. 23.
- Castro A, Trejos A. Constatación del primer caso centroamericano de Coccidioidomicosis. Rev Biol Trop. 1953;83-93.
- Hidalgo W, Xinirachs H, Cappella E, Solano E. Un caso de actinomicosis cervicofacial por Actinomyces bovis. Rev Biol Trop. 1960;8(2):155-63.
- 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.
- Brizuela S, Montero N. Criptococosis asociado a VIH/SIDA (A propósito de un paciente). Rev. méd. Costa Rica Centroam. 2013;70(605):43-7.
- 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.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2023
Primary Completion (Actual)
May 24, 2024
Study Completion (Actual)
May 24, 2024
Study Registration Dates
First Submitted
July 23, 2024
First Submitted That Met QC Criteria
July 26, 2024
First Posted (Actual)
July 29, 2024
Study Record Updates
Last Update Posted (Actual)
July 29, 2024
Last Update Submitted That Met QC Criteria
July 26, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Parasitic Diseases
- Protozoan Infections
- Skin Diseases, Infectious
- Mycoses
- Skin Diseases, Bacterial
- Dermatomycoses
- Lung Diseases, Fungal
- Nocardia Infections
- Infections
- Communicable Diseases
- Blastomycosis
- Sporotrichosis
- Coccidioidomycosis
- Coccidiosis
- Mycetoma
- Paracoccidioidomycosis
- Actinomycosis
Other Study ID Numbers
- R023-SABI-00344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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