Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

NCT ID: NCT02819232

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 442 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-12
• Study Completion Date: 2022-10-26

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.

Conditions

Infectious Keratitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with a prescription of a microbiologic diagnostic of

Patient with a prescription of a microbiologic diagnostic of keratitis

Group Type: OTHER

Blood sampling

Intervention Type: OTHER

Detection of bacteria will be performed on a blood sample

Interventions

Blood sampling

Detection of bacteria will be performed on a blood sample

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Drancourt, Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2012-A01568-35

Identifier Type: OTHER

Identifier Source: secondary_id

2012-40

Identifier Type: -

Identifier Source: org_study_id