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

Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05183906
Collaborator
(none)
100
1
17.7
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Next generation sequencing

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing in Infectious Keratitis
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Number of clinically relevant microorganisms identified using culture or next generation sequencing [1 year]

  2. Comparison of clinically relevant identified microorganisms on a genus level [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, Aarhus University Hospital Aarhus Denmark DK-8000

Sponsors and Collaborators

  • Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anders Ivarsen, Consultant, Associate Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT05183906
Other Study ID Numbers:
  • KeratitisMicrobiome
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022