Clinical trial NCT02984904: Fusarium Keratitits in Spain 2012 to 2014
Official title: Multicenter Study About Fusarium Keratitits in Spain 2012 to 2014
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Ulcer
Fusarium Infection
Keywords: Fusarium Infection
Corneal ulcer
Spain
Epidemiology
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
First posted: 2016-12-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Person diagnosed with keratitis secondary to Fusarium spp., During the study period

Brief summary: The aim of this study was to describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp., In Spain during the years 2012 to 2014.

Detailed description: Corneal ulcers are the second cause of preventable blindness in tropical countries, which are produced by a wide variety of eye infections that can lead to visual impairment, As a consequence of the cicatrization of the lesions caused. The World Health Organization (WHO) estimates that around 1.5-2.0 million new cases of monocular blindness secondary to this type of lesions occur every year.

Corneal ulceration is attributed to mycotic aetiology between 6 and 53% of the cases, recognising at least 70 different genera. Studies in developing countries have reported the presence of a wide variety of pathogenic fungi isolated from corneal ulcers, most prominently highlighting Candida spp. And Aspergillus spp., however, the appearance of less common fungal pathogens, but of great medical importance, owing to increased morbidity in healthy patients and especially in the immunocompromised population. These pathogens include the filamentous fungi Fusarium spp.

Fusarium spp. Is a universally distributed opportunistic fungus, ubiquitous and of great economic importance because it is usually phytopathogenic. This fungus causes human infections such as keratitis, endophthalmitis, among others. A predisposing factor for Fusarium spp. Is the corneal trauma, with an incidence ranging from 7% to 89.9%. Some research shows that these lesions were caused by different agents, it includes plant material (rice, hawthorn, hay, among others), animal (insects, cat scratch, among others), dust, earth, mud, stones, glass, metal objects and nails. Other factors that affect the appearance of keratitis by this type of fungus include the use of topical corticosteroids, previous eye surgery, pre-existing eye diseases (lagophthalmos, chronic dacryocystitis, corneal scarring or corneal ulcer), systemic diseases such as diabetes mellitus, leprosy, among others. These mycotic infections tend to be resistant to conventional antifungal agents, presenting more severe complications than other types of infections.

The epidemiological pattern of Fusarium spp. keratitis varies from country to country, predominating in regions that share climatic conditions, as described in Florida, Ghana, and China. Even in one country, its distribution is not homogeneous, as evidenced by studies in southern India, between the years 1991 to 2000, where 1360 mycotic keratitis was present, 506 (37.2%) attributed to Fusarium spp. By contrast, a study conducted in northern India over 6 years found 61 cases of mycotic keratitis, 10 of them (16.4%) secondary to Fusarium spp.

In June 2006, the Centers for Disease Control and Prevention (CDC) confirmed an outbreak of Fusarium spp., In 164 patients with contact lenses in 33 states and 1 US territory, being the most important outbreak reported in this country.

The keratitis caused by Fusarium spp. Occurs infrequently in European countries with temperate climates. A study conducted in Paris between 1993 and 2001 reported 19 mycotic keratitis, 4 cases (21%) attributed to Fusarium spp.

In Spain, it has been realised clinical case studies of Fusarium spp, however, no descriptions of the epidemiological profile have been made.The aim of this study was to describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp., In Spain during the years 2012 to 2014.

Eligibility criteria: Inclusion Criteria: Growth in the microbiological culture of Fusarium spp. In ocular samples informed by the participating centers confirmed or not by the National Center of Microbiology of the Carlos III Health Institute (ISC III) of Spain, admitting only one registry per patient / year -

Exclusion Criteria: Patients who could not be contacted because they did not reside in Spain or who did not accept the same

-

Primary outcomes:
measure: Describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp
timeFrame: 2012 to 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CLINICA BARRAQUER
name: José Larmarca Mateu, MD
role: STUDY_CHAIR
affiliation: HOSPITAL BELLVITGE
name: Tomas Marti Huguet, MD
role: STUDY_CHAIR
affiliation: HOSPITAL UNIVERSITARIO VALL DE HEBRON
name: Sara Martin, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Princesa
name: Paula Marticorena Alvarez, MD
role: STUDY_CHAIR
affiliation: Complejo Hospitalario de Navarra
name: Andres Garralda Luquin, MD
role: STUDY_CHAIR
affiliation: HOSPITAL GALDAKAO
name: Carlos Lopez Gutierrez, MD
role: STUDY_CHAIR
affiliation: HOSPITAL TXAGORRITXU - HOSPITAL UNIVERSITARIO ARABA
name: Jesus Garrido Fierro, MD
role: STUDY_CHAIR
affiliation: HOSPITAL LAS CRUCES
name: Raquel Feijó Lera, MD
role: STUDY_CHAIR
affiliation: HOSPITAL GENERAL JUAN RAMÓN JIMENEZ
name: Juan Carlos Sanchez España, MD
role: STUDY_CHAIR
affiliation: HOSPITAL DOCTOR NEGRIN
name: Graciela Trujillo, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario San Juan de Alicante
name: Encarnacio Mengual Verdu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario San Juan de Alicante
name: Victor Garcia, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario San Juan de Alicante
name: Miguel A Mosquera Gordillo, MD
role: STUDY_DIRECTOR
affiliation: Miguel Hernandez University (MPH)
name: Natalia Baron Cano, Nurse
role: STUDY_CHAIR
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