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Trial record 18 of 594 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs (Keratite)

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ClinicalTrials.gov Identifier: NCT02819232
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
Infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome rheumatoid arthritis, or much more frequently wearing contact lenses. If the majority of infectious keratitis are favourable, some lead to serious injury of the cornea, or even corneal perforation which result an endophthalmitis. This unfavourable evolution may lead to blindness due to corneal damage, the endo-ocular lesions or enucleation of the eyeball. This negative evolution is encountered while the infectious keratitis due to tedious germs of difficult diagnosis such as nontuberculous Mycobacterial, fungal infections, fungal keratitis, amoebic keratitis, and certain viral keratitis. The microbiological diagnosis of routine is based on the systematic search for pathogens tedious from invasive sampling of cornea by vaccinostyle. We set up a new non-invasive corneal swab diagnostic method.

Condition or disease Intervention/treatment Phase
Infectious Keratitis Other: Blood sampling Not Applicable

Detailed Description:

Primary Purpose: Compare the ability diagnostic of non-invasive sampling swab corneal versus the gold standard, (invasive vaccinostyle uptake) for the systematic search for pathogens tedious in corneal specimens.

Hypothesis:

The diagnostic strategy using a microbial testing of cornea method has a sensitivity of 90% and a specificity of 80% or more over the policy diagnostic using a sampling by vaccinostyle method.

Primary outcome measures: Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 864 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs
Study Start Date : March 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patient with a prescription of a microbiologic diagnostic of
Patient with a prescription of a microbiologic diagnostic of keratitis
Other: Blood sampling
Detection of bacteria will be performed on a blood sample




Primary Outcome Measures :
  1. Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio. [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is more than 18 years old.
  • Patient with a prescription of a microbiologic diagnostic of keratitis
  • Patient who do not declined to have his medical records reviewed for research
  • Patient with health insurance

Exclusion Criteria:

  • minor patient (<18 years).
  • Pregnant or breastfeeding women.
  • Major Patient under guardianship.
  • Patient in vital emergency.
  • Private Patient liberty or under court order.
  • Patient refusing to sign the informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819232


Contacts
Contact: Michel Drancourt, Pr 0491385519 ext +33 michel.drancourt@ap-hm.fr
Contact: Alexandra Giuliani 0491382870 ext +33 alexandra.giuliani@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Michel DRANCOURT, Pr    04 91 38 55 19 ext +33    michel.drancourt@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Michel Drancourt, Pr Assistance Publique - Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02819232     History of Changes
Other Study ID Numbers: 2012-40
2012-A01568-35 ( Other Identifier: ANSM )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Communicable Diseases
Infection
Keratitis
Corneal Diseases
Eye Diseases