NCT05183906

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
Same day until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

December 9, 2021

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

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

Locations