NCT02984904

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Last Updated

December 7, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

November 17, 2016

Last Update Submit

December 2, 2016

Conditions

Corneal UlcerFusarium Infection

Keywords

Fusarium InfectionCorneal ulcerSpainEpidemiology

Outcome Measures

Primary Outcomes (1)

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

    epidemiological survey

    2012 to 2014

Interventions

surveyOTHER

survey

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • 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.

    PMID: 1985498RESULT

  • 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.

    PMID: 18608899RESULT

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

    PMID: 11285665RESULT

  • 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.

    PMID: 9505820RESULT

  • 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.

    PMID: 17657018RESULT

  • 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.

    PMID: 12131029RESULT

  • 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.

    PMID: 15829742RESULT

  • 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.

    PMID: 18204773RESULT

  • 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.

    PMID: 15355406RESULT

  • 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.

    PMID: 10832689RESULT

  • 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.

    PMID: 20944931RESULT

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

    PMID: 16575115RESULT

  • 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.

    PMID: 21836342RESULT

  • 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.

    PMID: 18245962RESULT

  • 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.

    PMID: 12386069RESULT

  • Rosa RH Jr, Miller D, Alfonso EC. The changing spectrum of fungal keratitis in south Florida. Ophthalmology. 1994 Jun;101(6):1005-13. doi: 10.1016/s0161-6420(94)31225-5.

    PMID: 8008340RESULT

  • Xie L, Dong X, Shi W. Treatment of fungal keratitis by penetrating keratoplasty. Br J Ophthalmol. 2001 Sep;85(9):1070-4. doi: 10.1136/bjo.85.9.1070.

    PMID: 11520759RESULT

  • Chander J, Sharma A. Prevalence of fungal corneal ulcers in northern India. Infection. 1994 May-Jun;22(3):207-9. doi: 10.1007/BF01716706.

    PMID: 7927819RESULT

  • Chang DC, Grant GB, O'Donnell K, Wannemuehler KA, Noble-Wang J, Rao CY, Jacobson LM, Crowell CS, Sneed RS, Lewis FM, Schaffzin JK, Kainer MA, Genese CA, Alfonso EC, Jones DB, Srinivasan A, Fridkin SK, Park BJ; Fusarium Keratitis Investigation Team. Multistate outbreak of Fusarium keratitis associated with use of a contact lens solution. JAMA. 2006 Aug 23;296(8):953-63. doi: 10.1001/jama.296.8.953.

    PMID: 16926355RESULT

  • Rondeau N, Bourcier T, Chaumeil C, Borderie V, Touzeau O, Scat Y, Thomas F, Baudouin C, Nordmann JP, Laroche L. [Fungal keratitis at the Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: retrospective study of 19 cases]. J Fr Ophtalmol. 2002 Nov;25(9):890-6. French.

    PMID: 12515932RESULT

  • Donnio A, Van Nuoi DN, Catanese M, Desbois N, Ayeboua L, Merle H. Outbreak of keratomycosis attributable to Fusarium solani in the French West Indies. Am J Ophthalmol. 2007 Feb;143(2):356-8. doi: 10.1016/j.ajo.2006.09.021. Epub 2006 Oct 20.

    PMID: 17258535RESULT

Related Links

MeSH Terms

Conditions

Corneal UlcerFusariosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsKeratitisCorneal DiseasesEye DiseasesHyalohyphomycosisDermatomycosesMycosesBacterial Infections and MycosesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • 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

    STUDY CHAIR

  • Encarnacio Mengual Verdu, MD

    Hospital Universitario San Juan de Alicante

    PRINCIPAL INVESTIGATOR

  • Victor Garcia, MD

    Hospital Universitario San Juan de Alicante

    STUDY CHAIR

  • Miguel A Mosquera Gordillo, MD

    Hospital Universitario San Juan de Alicante

    STUDY DIRECTOR

  • Natalia Baron Cano, Nurse

    Miguel Hernandez University (MPH)

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 17, 2016

First Posted

December 7, 2016

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

August 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-11