Fusarium Keratitits in Spain 2012 to 2014

December 2, 2016 updated by: Miguel Armando Mosquera Gordillo, MD

Multicenter Study About Fusarium Keratitits in Spain 2012 to 2014

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

23

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Person diagnosed with keratitis secondary to Fusarium spp., During the study period

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp
Time Frame: 2012 to 2014
epidemiological survey
2012 to 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this 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 Ramon 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMG-FUS-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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