Keratite: Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT02819232

Collaborator

(none)

864

Enrollment

Location

Arm

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infectious Keratitis	Other: Blood sampling	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

864 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient with a prescription of a microbiologic diagnostic of Patient with a prescription of a microbiologic diagnostic of keratitis	Other: Blood sampling Detection of bacteria will be performed on a blood sample

Arm

Intervention/Treatment

Other: Patient with a prescription of a microbiologic diagnostic of

Patient with a prescription of a microbiologic diagnostic of keratitis

Other: Blood sampling

Detection of bacteria will be performed on a blood sample

Outcome Measures

Primary Outcome Measures

Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio. [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator: Michel Drancourt, Pr, Assistance Publique - Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT02819232

Other Study ID Numbers:

2012-40
2012-A01568-35

First Posted:

Jun 30, 2016

Last Update Posted:

Jun 30, 2016

Last Verified:

Jun 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Communicable Diseases

Infections

Keratitis

Study Results

No Results Posted as of Jun 30, 2016