Clinical trial NCT06775808: Total Infectome Characterization of Eye Infections
Official title: Total Infectome Characterization of Eye Infections: a Metagenomic Sequencing Based Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eye Infections
Diagnosis
Keywords: infectome
metagenomic sequencing
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).

Brief summary: Multiple pathogens can cause eye infection. In recent years, emerging and resurging viral infections represent an important public health problem. Many emerging viruses cause infectious diseases involving ophthalmic manifestations, including Mpox virus, Zika, Ebola, and SARS-CoV-2. Broad and unbiased pathogen surveillance is essential, so we design this unbiased metagenomic sequencing based study to investigate the total infectome of eye infections. The study is historical and prospective in design.

Detailed description: This is an investigator-initiated observational study to describe the total infectome of eye infections using metagenomic sequencing. The eye infections, including acute conjunctivitis, keratitis, uveitis, and endophthalmitis, are diagnosed by experienced ophthalmologists according to routine clinical exams.

For the collection of additional biological samples apart from the diagnosis and treatment process, written informed consent is required from the eligible subjects or their legal guardians at the recruitment time is required. The application for exemption of informed consent has been made for using clinical surplus samples. After completing informed consent, subjects will be sampled, and their clinical information will be collected.

Biospecimens, including conjunctival sac swabs (1 swab for each involving eye), or intraocular fluid (more than 100μl), will be collected for metagenomic sequencing using the Illumina NovaSeq X Plus platform.

The clinical information of participants will be collated from electronic medical record information system, including (1) demographic characteristics: age, sex, comorbidities; (2) laboratory examination: blood routine test, immune inflammatory factors, clinical microbiology examination (PCR, serological examination, culture, etc.); (3) imaging examination: anterior segment photograph, corneal endothelial cell examination, corneal confocal microscopy, fundus photograph.

Meta-transcriptomic analysis of the ocular samples will be conducted to identify viruses, bacteria, fungi and parasites. The abundance of pathogens is indicated as the RPKM (i.e. Reads Per Million divided by the length of the reference genome, measured in kilobases).

Eligible participants will be recruited consecutively between August, 2024 and December, 2026 in Department of Ophthalmology, Shanghai General Hospital. The total study duration is expected to be two years from the first subject enrolled to the final analysis.

Eligibility criteria: Inclusion Criteria:

1. Patients with a clinical diagnosis of one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
2. Biological samples has been collected for clinical microbiological examination, or consented to participate in this study.

Exclusion Criteria:

1. Patients who have no historically clinical surplus specimens.

Primary outcomes:
measure: The pathogen profile
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Microbial abundance
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Hui Zhao, MPH
role: PRINCIPAL_INVESTIGATOR
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