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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Costa Rica
      • San José, Costa Rica, 10101
        • Hospital Rafael Ángel Calderón Guardia
      • San José, Costa Rica, 10103
        • Hospital San Juan de Dios
      • San José, Costa Rica, 10107
        • Hospital México

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Caja Costarricense de Seguro Social

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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