Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
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
| Condition(s) | Uveitis, Infectious Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 bel |
| Who can participate | Inclusion Criteria: * Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis * Presumed post-operative endophthalmitis * Unilateral or bilateral * 18 years and older Exclusion Criteria: * Insufficient specimen for MDS * Age \< 18 years of age * Pregnancy * Unable to consent |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of California, San Francisco |
| Locations | San Francisco, California, United States |
| Start date | 2022-06-06 |
| NCT ID | NCT05286203 |
| Official listing | https://clinicaltrials.gov/study/NCT05286203 |