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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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infectious Keratitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 28, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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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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