Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-24 @ 11:42 PM
Study NCT ID:
NCT02984904
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fusarium Keratitits in Spain 2012 to 2014
Sponsor:
Organization:
Raw JSON
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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': '18608899', 'type': 'RESULT', 'citation': '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': '11285665', 'type': 'RESULT', 'citation': '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': '9505820', 'type': 'RESULT', 'citation': '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': '17657018', 'type': 'RESULT', 'citation': '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': '12131029', 'type': 'RESULT', 'citation': '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': '15829742', 'type': 'RESULT', 'citation': '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': '18204773', 'type': 'RESULT', 'citation': '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': '15355406', 'type': 'RESULT', 'citation': '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': '10832689', 'type': 'RESULT', 'citation': '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': '20944931', 'type': 'RESULT', 'citation': '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': '16575115', 'type': 'RESULT', 'citation': 'Saha R, Das S. Mycological profile of infectious Keratitis from Delhi. Indian J Med Res. 2006 Feb;123(2):159-64.'}, {'pmid': '21836342', 'type': 'RESULT', 'citation': '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': '18245962', 'type': 'RESULT', 'citation': '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': '12386069', 'type': 'RESULT', 'citation': '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': '8008340', 'type': 'RESULT', 'citation': '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': '11520759', 'type': 'RESULT', 'citation': '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': '7927819', 'type': 'RESULT', 'citation': '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': '16926355', 'type': 'RESULT', 'citation': "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': '12515932', 'type': 'RESULT', 'citation': "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': '17258535', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.nepjol.info/index.php/NJMS/article/view/7651', 'label': 'Spectrum of Mycotic corneal ulcers in Mid Western peripheral region of Terrain belt of Nepal and Indo-Nepal Border'}, {'url': 'http://www.oftalmo.com/sco/revista-21/21sco06.htm', 'label': 'Queratitis micótica. Caso clínico. Arch Soc Canar Oftal \\[Internet\\]. 2006;17'}, {'url': 'http://www.oftalmo.com/sco/revista-21/21sco06.htm', 'label': 'Queratitis por Fusarium. A propósito de dos casos. Arch Soc Canar Oftal \\[Internet\\]. 2010;21'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nCorneal 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.\n\nFusarium 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.\n\nThe 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.\n\nIn 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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Person diagnosed with keratitis secondary to Fusarium spp., During the study period', 'healthyVolunteers': False, 'eligibilityCriteria': '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 -\n\nExclusion Criteria: Patients who could not be contacted because they did not reside in Spain or who did not accept the same\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02984904', 'briefTitle': 'Fusarium Keratitits in Spain 2012 to 2014', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'Multicenter Study About Fusarium Keratitits in Spain 2012 to 2014', 'orgStudyIdInfo': {'id': 'MMG-FUS-2015-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'OTHER', 'description': 'survey'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'José Larmarca Mateu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CLINICA BARRAQUER'}, {'name': 'Tomas Marti Huguet, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL BELLVITGE'}, {'name': 'Sara Martin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL UNIVERSITARIO VALL DE HEBRON'}, {'name': 'Paula Marticorena Alvarez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario La Princesa'}, {'name': 'Andres Garralda Luquin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Complejo Hospitalario de Navarra'}, {'name': 'Carlos Lopez Gutierrez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL GALDAKAO'}, {'name': 'Jesus Garrido Fierro, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL TXAGORRITXU - HOSPITAL UNIVERSITARIO ARABA'}, {'name': 'Raquel Feijó Lera, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL LAS CRUCES'}, {'name': 'Juan Carlos Sanchez España, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL GENERAL JUAN RAMÓN JIMENEZ'}, {'name': 'Graciela Trujillo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HOSPITAL DOCTOR NEGRIN'}, {'name': 'Encarnacio Mengual Verdu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario San Juan de Alicante'}, {'name': 'Victor Garcia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario San Juan de Alicante'}, {'name': 'Miguel A Mosquera Gordillo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario San Juan de Alicante'}, {'name': 'Natalia Baron Cano, Nurse', 'role': 'STUDY_CHAIR', 'affiliation': 'Miguel Hernandez University (MPH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miguel Armando Mosquera Gordillo, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Complejo Hospitalario de Navarra', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Miguel Armando Mosquera Gordillo, MD', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}