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Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02819232
Acronym
Keratite
Enrollment
442
Registered
2016-06-30
Start date
2013-08-12
Completion date
2022-10-26
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Keratitis

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.

Interventions

OTHERBlood sampling

Detection of bacteria will be performed on a blood sample

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026