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NCT05183906 Clinical Trial

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

Keratitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05183906
Other study ID # KeratitisMicrobiome
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 9, 2021
Est. completion date June 1, 2024

Study information
Verified date February 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Next generation sequencing
Evaluation of microbiological culturing versus next generation sequencing for ribosomal DNA

Locations
Country Name City State
Denmark Department of Ophthalmology, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of clinically relevant microorganisms identified using culture or next generation sequencing 1 year
Primary Comparison of clinically relevant identified microorganisms on a genus level 1 year
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