Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis

• Presumed post-operative endophthalmitis

• Unilateral or bilateral

• 18 years and older

Locations
United States
California
University of California San Francisco (UCSF)
RECRUITING
San Francisco
Contact Information
Primary
Jessica Shantha, MD
Jessica.shantha@ucsf.edu
(415) 476-1442
Backup
Thuy Doan, MD, PhD
415-476-6939
Time Frame
Start Date: 2022-06-06
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Active_comparator: Standard of Care
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
Experimental: MDS
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: University of Nebraska, University of Utah, University of California, Davis, University of California, Los Angeles

This content was sourced from clinicaltrials.gov