Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Infectious Keratitis Clinical Trial

— Keratite  

Official title:

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819232
• Other study ID #: 2012-40
• Secondary ID: 2012-A01568-35
• Status: Completed
• Phase: N/A
• Start date: August 12, 2013
• Est. completion date: October 26, 2022

Study information

• Verified date: April 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: October 26, 2022
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Keratitis
• Keratitis

Intervention

Other:
• Blood sampling
Detection of bacteria will be performed on a blood sample

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.		1 day