Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02984904
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2016-11-17
Brief Title:
Fusarium Keratitits in Spain 2012 to 2014
Sponsor:
Miguel Armando Mosquera Gordillo MD
Organization:
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study Overview
Official Title:
Multicenter Study About Fusarium Keratitits in Spain 2012 to 2014
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15-20 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 899 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 506 372 attributed to Fusarium spp By contrast a study conducted in northern India over 6 years found 61 cases of mycotic keratitis 10 of them 164 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 madeThe 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
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 899 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 506 372 attributed to Fusarium spp By contrast a study conducted in northern India over 6 years found 61 cases of mycotic keratitis 10 of them 164 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 madeThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None