Shanghai General Hospital
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
NCT Number: NCT06775808
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.
Interested in participating?
Request InfoAll sexes
Observational
Shanghai, Shanghai Municipality, 200030, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 2 year
The bacteria, fungi, viruses, and parasites identified through metagenomic techniques in ocular samples.
Time frame: through study completion, an average of 2 year
The pathogen abundance is measure by the RPKM (i.e. Reads Per Million divided by the length of the reference genome, measured in kilobases).
Contact information is provided by the study sponsor or research team.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
Total Infectome Characterization of Eye Infections: a Metagenomic Sequencing Based Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06579170
Blue Green Algae Poisoning, Cellulitis
Winnipeg, Manitoba, Canada
View Trial DetailsNCT06720467
Eye Diseases, Eye Infections
Zagazig, Egypt
View Trial DetailsNCT03553017
Endophthalmitis, Eye Diseases
London, United Kingdom
View Trial DetailsNCT01739920
Endophthalmitis, Eye Diseases
Ribeirão Preto, São Paulo, Brazil
View Trial Details