At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
In Brief
A clinical study evaluating Metagenomic Deep Sequencing (MDS) and Standard of Care (SOC) for Uveitis and Infectious Disease. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
Interventions
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.
SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.