NCT05286203

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uveitis
• Infectious Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-03-18
• Last updated: 2022-07-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study