NCT02819232

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Blood sampling	Detection of bacteria will be performed on a blood sample

Timeline

• Start date: 2013-08-12
• Primary completion: 2019-03-06
• Completion: 2022-10-26
• First posted: 2016-06-30
• Last updated: 2023-04-21

Locations

1 site across 1 country: France