Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05286203
NA

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-06-06

Completion Date

2026-12

Last Updated

2022-07-07

Healthy Volunteers

No

Interventions

DEVICE

Metagenomic Deep Sequencing (MDS)

MDS is an RNA-seq based testing of ocular fluid or tissue to identify potential infectious pathogens including bacteria, fungi, parasites, and DNA and RNA viruses.

DIAGNOSTIC_TEST

Standard of Care (SOC)

SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.

Locations (1)

University of California San Francisco (UCSF)

San Francisco, California, United States