The Effect of Metagenomic Sequencing on Patient Clinical Outcomes for Intraocular Infections: A Multicenter Randomized Controlled Trial.
Jessica G Shantha, Kareem Moussa, Wipada Laovirojjanakul...
https://pubmed.ncbi.nlm.nih.gov/40653257Actively Recruiting
Led by University of California, San Francisco · Updated on 2022-07-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of California, San Francisco
Lead Sponsor
U
University of Nebraska
Collaborating Sponsor
Researchers are studying people with presumed intraocular infections, including various types of uveitis and post-operative endophthalmitis, to compare two testing methods. The trial evaluates whether metagenomic deep sequencing (MDS) of ocular fluid or tissue can improve patient outcomes compared to standard diagnostic tests like Gram stain, cultures, and PCR. The goal is to see if MDS helps guide appropriate therapy and improves clinical results. Participants will be randomly assigned to one of two groups. One group receives standard of care testing, while the other group receives both standard testing and MDS testing. All patients will be treated based on standard care, with the addition of MDS results for the experimental group. The trial includes follow-up visits at week 2, between weeks 3 and 6 (randomization visit), and 4 weeks after randomization. During the study, researchers will measure if patients receive the correct therapy and their clinical improvement four weeks after randomization. They will also assess provider certainty, patient quality of life, infection status, and provider quality of care. Participants can expect eye exams, testing of ocular samples, and questionnaires during scheduled visits. The total duration of participation spans several weeks with close monitoring.
CONDITIONS
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks after randomization
Participants undergo standard of care diagnostic testing and may also receive metagenomic deep sequencing testing to identify potential infectious pathogens.
1 to 2 visits depending on assigned testing
Duration - Up to 4 weeks after randomization
Participants are monitored for clinical improvement, infection status, and quality of life outcomes following diagnostic testing.
Follow-up visits as needed within 4 weeks
Total: 1 location
1
University of California San Francisco (UCSF)
San Francisco, California, United States, 94158
Actively Recruiting
J
Jessica Shantha, MD
T
Thuy Doan, MD, PhD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Jessica G Shantha, Kareem Moussa, Wipada Laovirojjanakul...
https://pubmed.ncbi.nlm.nih.gov/40653257