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

Recruiting

• Conditions: Keratitis

• Registration Number: NCT05183906
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study Start: 2021-12-09
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of clinically relevant identified microorganisms on a genus level	1 year
Number of clinically relevant microorganisms identified using culture or next generation sequencing	1 year

Trial Locations

Locations (1)

Department of Ophthalmology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark