Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

NCT02819232 | Completed

• 2 other identifiers: 2012-402012-A01568-35
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Keratitis

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio.

  1 day

Study Arms (1)

Patient with a prescription of a microbiologic diagnostic of

OTHER

Patient with a prescription of a microbiologic diagnostic of keratitis

Other: Blood sampling

Interventions

Blood sampling OTHER

Detection of bacteria will be performed on a blood sample

Patient with a prescription of a microbiologic diagnostic of

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michel Drancourt, Pr

  Assistance Publique - Hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: August 12, 2013
• Primary Completion: March 6, 2019
• Study Completion: October 26, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)