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CompletedNCT05183906Updated Oct 28, 2026

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

An observational study in Keratitis, sponsored by Aarhus University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Aarhus University Hospital · Observational

Updated Oct 28, 2026Now CompletedEnrollment updatedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
57
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Keratitis

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03

In context

Keratitis

108 studies on the registry are indexed under Keratitis; 19 are open to participants now.

This study's enrollment of 57 is below the median of 105 across 31 observational studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with keratitis admitted to tertiary ophthalmological unit

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

- Patients below 18 years of age

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
57 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testNext generation sequencing

    Evaluation of microbiological culturing versus next generation sequencing for ribosomal DNA

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

  2. Comparison of clinically relevant identified microorganisms on a genus level

    Time frame: 1 year

07

Study locations

1 site
  • Department of Ophthalmology, Aarhus University Hospital
    Aarhus, DK-8000, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Jun 2024, 29 months.

Of 16 observational studies under Keratitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 34. This study's 29 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2021
First posted
Jan 11, 2022
StartActual
Dec 9, 2021
Primary completionActual
Jun 1, 2024
CompletionActual
Jun 1, 2024
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 28, 2026
Enrollment
100 (estimated)→57 (actual)
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Recruiting→Completed
    Enrollment 100 (estimated)→57 (actual)
    + 6 other changes: verification date, date precision, criteria formatting, site details, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05183906
Responsible party
Anders Ivarsen (Consultant, Associate Professor, Aarhus University Hospital) — Principal investigator
First posted
Jan 11, 2022
Start date
Dec 9, 2021
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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