SporotrichosisNCT06523998
A Study on Rare Dermatological Infections Conducted at Three Major Reference Hospitals in Costa Rica.
An observational study of Sporotrichosis and Chromomycosis, run by Caja Costarricense de Seguro Social at 3 sites in Costa Rica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Sporotrichosis, Chromomycosis, Actinomycosis
- How many people
- 95 participants
- Where
- 3 sitesCosta Rica
- Study dates
- 11 Dec 2023to 24 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Costa Rica3 sites
Hospital Rafael Ángel Calderón Guardia
San José, 10101
Hospital San Juan de Dios
San José, 10103
Hospital México
San José, 10107
About this study
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
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.
- Conditions
- Sporotrichosis, Chromomycosis, Actinomycosis, Nocardiosis, Mycetoma, Mycobacterial Cutaneous Infection
- Keywords
- Bacterial Infections and Mycoses, Infectious Skin Diseases, Sporotrichosis, Chromoblastomycosis, Mycetoma, Non-tuberculous mycobacteria
- Medical subject headings
- Sporotrichosis, Chromoblastomycosis, Actinomycosis, Nocardia Infections, Mycetoma, Coccidioidomycosis, Blastomycosis, Paracoccidioidomycosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze epidemiological, clinical, and therapeutic profile
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.
Measured: 5 year
Determine the risk factors
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.
Measured: 5 year
Determine the diagnostic methods
Determine the diagnostic methods utilized for each case, including culture, histological techniques, and molecular testing.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start11 Dec 2023
- Primary completion24 May 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for SporotrichosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caja Costarricense de Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniel Barquero Orias, Caja Costarricense de Seguro Social
- Investigators
- Daniel E Barquero Orias, MD, Principal investigator, Caja Costarricense de Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523998
- Sponsor's protocol ID
- R023-SABI-00344
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06523998
- Acronym / sponsor ID
- R023-SABI-00344
- Conditions
- Sporotrichosis, Chromomycosis, Actinomycosis, Nocardiosis, Mycetoma, Mycobacterial Cutaneous Infection
- Keywords
- Bacterial Infections and Mycoses, Infectious Skin Diseases, Sporotrichosis, Chromoblastomycosis, Mycetoma, Non-tuberculous mycobacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Caja Costarricense de Seguro SocialOther government
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Determine the diagnostic methods
Time frame: 5 year
Determine the diagnostic methods utilized for each case, including culture, histological techniques, and molecular testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- BackgroundBolognia JL, Schaffer JV, Cerroni L, Callen JP. Dermatología. 4th ed. Barcelona: Elsevier; 2019.
- BackgroundKang S, Amagai M, Bruckner AL, Enk AH, Margolis DJ, McMichael AJ, et al. Fitzpatrick's Dermatology. 9th ed. New York: McGraw-Hill Education; 2019.
- BackgroundTrejos 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.
- BackgroundTrejos A. Cladosporium carrionii n. sp. and the problem of Cladosporia isolated from chromoblastomycosis. Rev Biol Trop. 1954, 2(1):75-112.
- BackgroundMora 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.
- BackgroundRomero A, Trejos A. La cromomicosis en Costa Rica. Rev Biol Trop. 1953;1(2):95-115.
- BackgroundSoto L, Jaikel D. Cromoblastomicosis: Situación en Costa Rica. Rev. méd. Costa Rica Centroam. 2014;71(613):737-44.
- BackgroundSalazar 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
- BackgroundSolano E. Cromomicosis. Acta Med Costarr. 1966;9(2):77-85.
- BackgroundAstorga 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.
- BackgroundSáenz L, Morera P. Sobre un caso de blastomicosis suramericana asociada a cromomicosis. Acta Med Costarr. 1963;6(1):55-71.
- BackgroundAlice E. Ecología de Sporothrix schenkii. Rev Méd de Costa Rica. 1982;49(479):81-6.
- Individual participant dataSharing planned: No
Related trials for Sporotrichosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Barquero Orias, MD principal investigator
Caja Costarricense de Seguro Social
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sporotrichosis and Chromomycosis, run by Caja Costarricense de Seguro Social at 3 sites in Costa Rica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze epidemiological, clinical, and therapeutic profile (time frame: 5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523998, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.