Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Not Applicable

Completed

• Conditions: Infectious Keratitis
• Interventions: Other: Blood sampling

• Registration Number: NCT02819232
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-08-12
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Primary Completion: 2019-03-06
• Study Completion: 2022-10-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with a prescription of a microbiologic diagnostic of	Blood sampling	Patient with a prescription of a microbiologic diagnostic of keratitis

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.	1 day

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France