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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05183906

Enrollment

100

Registered

2022-01-11

Start date

2021-12-09

Completion date

2024-06-01

Last updated

2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratitis

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.

Interventions

DIAGNOSTIC_TESTNext generation sequencing

Evaluation of microbiological culturing versus next generation sequencing for ribosomal DNA

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026