Fusarium Keratitits in Spain 2012 to 2014
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|ClinicalTrials.gov Identifier: NCT02984904|
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
|Condition or disease||Intervention/treatment|
|Corneal Ulcer Fusarium Infection||Other: survey|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||23 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Multicenter Study About Fusarium Keratitits in Spain 2012 to 2014|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||August 2016|
- Other: survey
- Describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp [ Time Frame: 2012 to 2014 ]epidemiological survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984904
|Study Chair:||José Larmarca Mateu, MD||CLINICA BARRAQUER|
|Study Chair:||Tomas Marti Huguet, MD||HOSPITAL BELLVITGE|
|Study Chair:||Sara Martin, MD||HOSPITAL UNIVERSITARIO VALL DE HEBRON|
|Study Chair:||Paula Marticorena Alvarez, MD||HOSPITAL UNIVERSITARIO LA PRINCESA|
|Study Chair:||Andres Garralda Luquin, MD||Complejo Hospitalario de Navarra|
|Study Chair:||Carlos Lopez Gutierrez, MD||HOSPITAL GALDAKAO|
|Study Chair:||Jesus Garrido Fierro, MD||HOSPITAL TXAGORRITXU - HOSPITAL UNIVERSITARIO ARABA|
|Study Chair:||Raquel Feijó Lera, MD||HOSPITAL LAS CRUCES|
|Study Chair:||Juan Carlos Sanchez España, MD||HOSPITAL GENERAL JUAN RAMÓN JIMENEZ|
|Study Chair:||Graciela Trujillo, MD||HOSPITAL DOCTOR NEGRIN|
|Principal Investigator:||Encarnacio Mengual Verdu, MD||Hospital Universitario San Juan de Alicante|
|Study Chair:||Victor Garcia, MD||Hospital Universitario San Juan de Alicante|
|Study Director:||Miguel A Mosquera Gordillo, MD||Hospital Universitario San Juan de Alicante|
|Study Chair:||Natalia Baron Cano, Nurse||Miguel Hernandez University (MPH)|