Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing for Microbiological Assessment in Infectious Keratitis
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedStudy Start
First participant enrolled
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 2, 2024
February 1, 2024
2.5 years
December 9, 2021
February 1, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Interventions
Evaluation of microbiological culturing versus next generation sequencing for ribosomal DNA
Eligibility Criteria
Patients with keratitis admitted to tertiary ophthalmological unit
You may qualify if:
- \- Patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea
You may not qualify if:
- \- Patients below 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Aarhus University Hospital
Aarhus, DK-8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, Associate Professor
Study Record Dates
First Submitted
December 9, 2021
First Posted
January 11, 2022
Study Start
December 9, 2021
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
February 2, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share