Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Not Applicable

Recruiting

• Conditions: Uveitis; Infectious Disease
• Interventions: Device: Metagenomic Deep Sequencing (MDS); Diagnostic Test: Standard of Care (SOC)

• Registration Number: NCT05286203
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-18
• Study Start: 2022-06-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Insufficient specimen for MDS
• Age < 18 years of age
• Pregnancy
• Unable to consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDS	Metagenomic Deep Sequencing (MDS)	Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
Standard of Care	Standard of Care (SOC)	Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.

Primary Outcome Measures

Name	Time	Method
Appropriate therapy	4-week after randomization	Dichotomous variable (Y/N) as determined by an independent expert panel
Clinical improvement	4-week after randomization	Dichotomous variable (Y/N) as assessed by a masked evaluator

Secondary Outcome Measures

Name	Time	Method
Provider certainty of belief	4-week after randomization	Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)
Provider quality of care	4-week after randomization	As measured by the World Health Organization Quality of Life Abbreviated Questionnaire (min = 0, max = 100; higher means better quality of life).
Patient quality of life	4-week after randomization	As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
Infection status	4-week after randomization	Estimated through latent class analysis that compares MDS with traditional tests for presumed ocular infections. Sensitivity and specificity will be reported as percentage (%)

Trial Locations

Locations (1)

University of California San Francisco (UCSF); 🇺🇸 San Francisco, California, United States