An interventional study of Blood sampling in Infectious Keratitis, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic
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.
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.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's enrollment of 442 is above the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with a prescription of a microbiologic diagnostic of keratitis
Other: Blood sampling
Detection of bacteria will be performed on a blood sample
Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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