Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05286203
Status
Recruiting
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Conditions

  • Infectious Disease
  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metagenomic Deep Sequencing (MDS) — DEVICE
    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.
  • Standard of Care (SOC) — DIAGNOSTIC_TEST
    SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.

Study Details

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 Dates

Start date
Jun 6, 2022
Status verified
Jul 2022
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Clinical improvement [ Time Frame: 4-week after randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Francisco (UCSF)San FranciscoCalifornia94158
Jessica Shantha, MD, MAS
[email protected]
Thuy Doan, MD, PhD
415-476-6939

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