Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs (Keratite)
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|ClinicalTrials.gov Identifier: NCT02819232|
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infectious Keratitis||Other: Blood sampling||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||864 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||September 2019|
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
- Sensitivity, specificity, positive and negative predictive values, Diagnostic odds ratio. [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819232
|Contact: Michel Drancourt, Pr||0491385519 ext +email@example.com|
|Contact: Alexandra Giuliani||0491382870 ext +firstname.lastname@example.org|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Michel DRANCOURT, Pr 04 91 38 55 19 ext +33 email@example.com|
|Principal Investigator:||Michel Drancourt, Pr||Assistance Publique - Hôpitaux de Marseille|