Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05286203

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Led by University of California, San Francisco · Updated on 2022-07-07

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

University of Nebraska

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying people with presumed intraocular infections, including various types of uveitis and post-operative endophthalmitis, to compare two testing methods. The trial evaluates whether metagenomic deep sequencing (MDS) of ocular fluid or tissue can improve patient outcomes compared to standard diagnostic tests like Gram stain, cultures, and PCR. The goal is to see if MDS helps guide appropriate therapy and improves clinical results. Participants will be randomly assigned to one of two groups. One group receives standard of care testing, while the other group receives both standard testing and MDS testing. All patients will be treated based on standard care, with the addition of MDS results for the experimental group. The trial includes follow-up visits at week 2, between weeks 3 and 6 (randomization visit), and 4 weeks after randomization. During the study, researchers will measure if patients receive the correct therapy and their clinical improvement four weeks after randomization. They will also assess provider certainty, patient quality of life, infection status, and provider quality of care. Participants can expect eye exams, testing of ocular samples, and questionnaires during scheduled visits. The total duration of participation spans several weeks with close monitoring.

CONDITIONS

Brief Title

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presumed infectious anterior uveitis, intermediate uveitis, posterior uveitis, or panuveitis
  • Presumed post-operative endophthalmitis
  • Unilateral or bilateral infection
  • 18 years and older
Not Eligible

You will not qualify if you...

  • Insufficient specimen for metagenomic deep sequencing
  • Under 18 years of age
  • Pregnancy
  • Unable to give informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 weeks after randomization

Participants undergo standard of care diagnostic testing and may also receive metagenomic deep sequencing testing to identify potential infectious pathogens.

1 to 2 visits depending on assigned testing

Long-term Monitoring

Duration - Up to 4 weeks after randomization

Participants are monitored for clinical improvement, infection status, and quality of life outcomes following diagnostic testing.

Follow-up visits as needed within 4 weeks

Trial Site Locations

Total: 1 location

1

University of California San Francisco (UCSF)

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

J

Jessica Shantha, MD

T

Thuy Doan, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

The Effect of Metagenomic Sequencing on Patient Clinical Outcomes for Intraocular Infections: A Multicenter Randomized Controlled Trial.

Jessica G Shantha, Kareem Moussa, Wipada Laovirojjanakul...

https://pubmed.ncbi.nlm.nih.gov/40653257