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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
Sponsor:
Collaborator:
Complejo Hospitalario de Navarra
Information provided by (Responsible Party):
Miguel Armando Mosquera Gordillo, MD, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Tracking Information
First Submitted Date November 17, 2016
First Posted Date December 7, 2016
Last Update Posted Date December 7, 2016
Study Start Date April 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2016)
Describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp [ Time Frame: 2012 to 2014 ]
epidemiological survey
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fusarium Keratitits in Spain 2012 to 2014
Official Title Multicenter Study About Fusarium Keratitits in Spain 2012 to 2014
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.

Study Type Observational [Patient Registry]
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Person diagnosed with keratitis secondary to Fusarium spp., During the study period
Condition
  • Corneal Ulcer
  • Fusarium Infection
Intervention Other: survey
survey
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2016)
23
Original Actual Enrollment Same as current
Actual Study Completion Date August 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
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

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02984904
Other Study ID Numbers MMG-FUS-2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Miguel Armando Mosquera Gordillo, MD, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study Sponsor Miguel Armando Mosquera Gordillo, MD
Collaborators Complejo Hospitalario de Navarra
Investigators
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)
PRS Account Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Verification Date November 2016