Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs (Keratite)
Primary Purpose
Infectious Keratitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Infectious Keratitis
Eligibility 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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with a prescription of a microbiologic diagnostic of
Arm Description
Patient with a prescription of a microbiologic diagnostic of keratitis
Outcomes
Primary Outcome Measures
Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.
Secondary Outcome Measures
Full Information
NCT ID
NCT02819232
First Posted
June 28, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02819232
Brief Title
Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs
Acronym
Keratite
Official Title
Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2013 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Keratitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with a prescription of a microbiologic diagnostic of
Arm Type
Other
Arm Description
Patient with a prescription of a microbiologic diagnostic of keratitis
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Detection of bacteria will be performed on a blood sample
Primary Outcome Measure Information:
Title
Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Drancourt, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs
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