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Clinical Trials/NCT05183906
NCT05183906
Recruiting
Not Applicable

Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing in Infectious Keratitis

Aarhus University Hospital1 site in 1 country100 target enrollmentDecember 9, 2021
ConditionsKeratitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratitis
Sponsor
Aarhus University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Comparison of clinically relevant identified microorganisms on a genus level
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Infectious keratitis is a potential sight threatening condition. In conventional clinical practice culturing is performed in order to identify the causative microbial organism; however in recent years Next Generation Sequencing for the presence of ribosomal DNA from bacteria, fungi, or amoeba has become available. The present study aims to compare conventional culturing with Next Generation Sequencing for identifying microorganism causing keratitis.

Detailed Description

Patients admitted with microbial keratitis to the department of ophthalmology at Aarhus University Hospital is evaluated with both conventional culturing at agar plates, broth culture, and Next Generation Sequencing for ribosomal DNA. Only patients with a corneal infiltrate of a minimum of 2 mm or of 1 mm within the central 6 mm of the cornea will be included in the study. Sampling includes two samples from the contralateral healthy eye to control for the patient's normal microbiome, evaluated with culturing in broth and with NGS. From the infiltrate, samples include culturing on Sabouraud agar, chocolate agar, and blood agar, culturing in broth medium, and samples for NGS. A total of 100 patients will be included.

Registry
clinicaltrials.gov
Start Date
December 9, 2021
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Anders Ivarsen

Consultant, Associate Professor

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea

Exclusion Criteria

  • Patients below 18 years of age

Outcomes

Primary Outcomes

Comparison of clinically relevant identified microorganisms on a genus level

Time Frame: 1 year

Number of clinically relevant microorganisms identified using culture or next generation sequencing

Time Frame: 1 year

Study Sites (1)

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