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AzTrials

Corneal UlcerNCT02984904

Fusarium Keratitits in Spain 2012 to 2014

An observational study of Corneal Ulcer and Fusarium Infection, run by Miguel Armando Mosquera Gordillo, MD.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Corneal Ulcer, Fusarium Infection
What is being tested?
survey
How many people
23 participants
Where
No sites listed yet
Study dates
Apr 2015to Aug 2016
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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

-

About this study

Official title: 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.

Read the 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.

Being tested
survey
Keywords
Fusarium Infection, Corneal ulcer, Spain, Epidemiology
Medical subject headings
Corneal Ulcer, Fusariosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surveyOther

    survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp

    epidemiological survey

    Measured: 2012 to 2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
23 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02984904
Sponsor's protocol ID
MMG-FUS-2015-01
Status last verified
Nov 2016
First submitted
17 Nov 2016
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Upadhyay MP, Karmacharya PC, Koirala S, Tuladhar NR, Bryan LE, Smolin G, Whitcher JP. Epidemiologic characteristics, predisposing factors, and etiologic diagnosis of corneal ulceration in Nepal. Am J Ophthalmol. 1991 Jan 15;111(1):92-9. doi: 10.1016/s0002-9394(14)76903-x.

    PubMed 1985498

  • Ahearn DG, Zhang S, Stulting RD, Schwam BL, Simmons RB, Ward MA, Pierce GE, Crow SA Jr. Fusarium keratitis and contact lens wear: facts and speculations. Med Mycol. 2008 Aug;46(5):397-410. doi: 10.1080/13693780801961352. Epub 2008 Apr 4.

    PubMed 18608899

  • Whitcher JP, Srinivasan M, Upadhyay MP. Corneal blindness: a global perspective. Bull World Health Organ. 2001;79(3):214-21. Epub 2003 Jul 7.

    PubMed 11285665

  • Srinivasan M, Gonzales CA, George C, Cevallos V, Mascarenhas JM, Asokan B, Wilkins J, Smolin G, Whitcher JP. Epidemiology and aetiological diagnosis of corneal ulceration in Madurai, south India. Br J Ophthalmol. 1997 Nov;81(11):965-71. doi: 10.1136/bjo.81.11.965.

    PubMed 9505820

  • Bharathi MJ, Ramakrishnan R, Vasu S; Meenakshi; Palaniappan R. Aetiological diagnosis of microbial keratitis in South India - a study of 1618 cases. Indian J Med Microbiol. 2002 Jan-Mar;20(1):19-24.

    PubMed 17657018

  • Gopinathan U, Garg P, Fernandes M, Sharma S, Athmanathan S, Rao GN. The epidemiological features and laboratory results of fungal keratitis: a 10-year review at a referral eye care center in South India. Cornea. 2002 Aug;21(6):555-9. doi: 10.1097/00003226-200208000-00004.

    PubMed 12131029

  • Basak SK, Basak S, Mohanta A, Bhowmick A. Epidemiological and microbiological diagnosis of suppurative keratitis in Gangetic West Bengal, eastern India. Indian J Ophthalmol. 2005 Mar;53(1):17-22. doi: 10.4103/0301-4738.15280.

    PubMed 15829742

  • Norina TJ, Raihan S, Bakiah S, Ezanee M, Liza-Sharmini AT, Wan Hazzabah WH. Microbial keratitis: aetiological diagnosis and clinical features in patients admitted to Hospital Universiti Sains Malaysia. Singapore Med J. 2008 Jan;49(1):67-71.

    PubMed 18204773

  • Doczi I, Gyetvai T, Kredics L, Nagy E. Involvement of Fusarium spp. in fungal keratitis. Clin Microbiol Infect. 2004 Sep;10(9):773-6. doi: 10.1111/j.1469-0691.2004.00909.x.

    PubMed 15355406

  • Tanure MA, Cohen EJ, Sudesh S, Rapuano CJ, Laibson PR. Spectrum of fungal keratitis at Wills Eye Hospital, Philadelphia, Pennsylvania. Cornea. 2000 May;19(3):307-12. doi: 10.1097/00003226-200005000-00010.

    PubMed 10832689

  • Passos RM, Cariello AJ, Yu MC, Hofling-Lima AL. Microbial keratitis in the elderly: a 32-year review. Arq Bras Oftalmol. 2010 Jul-Aug;73(4):315-9. doi: 10.1590/s0004-27492010000400002.

    PubMed 20944931

  • Saha R, Das S. Mycological profile of infectious Keratitis from Delhi. Indian J Med Res. 2006 Feb;123(2):159-64.

    PubMed 16575115

  • Nath R, Baruah S, Saikia L, Devi B, Borthakur AK, Mahanta J. Mycotic corneal ulcers in upper Assam. Indian J Ophthalmol. 2011 Sep-Oct;59(5):367-71. doi: 10.4103/0301-4738.83613.

    PubMed 21836342

  • Green M, Apel A, Stapleton F. Risk factors and causative organisms in microbial keratitis. Cornea. 2008 Jan;27(1):22-7. doi: 10.1097/ICO.0b013e318156caf2.

    PubMed 18245962

  • Leck AK, Thomas PA, Hagan M, Kaliamurthy J, Ackuaku E, John M, Newman MJ, Codjoe FS, Opintan JA, Kalavathy CM, Essuman V, Jesudasan CA, Johnson GJ. Aetiology of suppurative corneal ulcers in Ghana and south India, and epidemiology of fungal keratitis. Br J Ophthalmol. 2002 Nov;86(11):1211-5. doi: 10.1136/bjo.86.11.1211.

    PubMed 12386069

Questions about this trial

What is this clinical trial studying?

An observational study of Corneal Ulcer and Fusarium Infection, run by Miguel Armando Mosquera Gordillo, MD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the clinical-epidemiological characteristics of a series of cases of fungal keratitis associated with Fusarium spp (time frame: 2012 to 2014). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02984904, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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