Eye InfectionsNCT06775808
Total Infectome Characterization of Eye Infections
An observational study of Eye Infections and Diagnosis, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Infections, Diagnosis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
Who may be able to join
- Patients with a clinical diagnosis of one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
- Biological samples has been collected for clinical microbiological examination, or consented to participate in this study.
Who cannot join
- 1. Patients who have no historically clinical surplus specimens.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200030
Mei Kang, MPH, 02136126064, mei.kang@shgh.cn
About this study
Official title: Total Infectome Characterization of Eye Infections: a Metagenomic Sequencing Based Observational Study
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.
Read the 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.
- Conditions
- Eye Infections, Diagnosis
- Keywords
- infectome, metagenomic sequencing
- Medical subject headings
- Eye Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eye infections cohort | Patients diagnosed with on one or more type of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathogen profile
The bacteria, fungi, viruses, and parasites identified through metagenomic techniques in ocular samples.
Measured: through study completion, an average of 2 year
Secondary outcomes (1)
Microbial abundance
The pathogen abundance is measure by the RPKM (i.e. Reads Per Million divided by the length of the reference genome, measured in kilobases).
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start25 Dec 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Eye InfectionsStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Fourth People's Hospital Tongji University, The Central Hospital of Huanggang
- Responsible party
- Principal investigator, Biao Yan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Shuo Su, PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775808
- Sponsor's protocol ID
- SHGH-CRU-2024516
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD could be available on request to the principle investigators.
Publications
Vasquez-Perez A, Magan T, Volpe G, Osborne SF, McFaul K, Vahdani K. Necrotizing Blepharoconjunctivitis and Keratitis in Human Monkeypox. JAMA Ophthalmol. 2023 Mar 1;141(3):285-288. doi: 10.1001/jamaophthalmol.2022.6253.
PubMed 36757718Rose-Nussbaumer J, Doan T. Role of Ophthalmology in Emerging Infectious Diseases. JAMA Ophthalmol. 2022 Oct 1;140(10):935. doi: 10.1001/jamaophthalmol.2022.4017.
PubMed 36069833Barshak MB, Durand ML, Gupta A, Mohareb AM, Dohlman TH, Papaliodis GN. State-of-the-Art Review: Ocular Infections. Clin Infect Dis. 2024 Nov 22;79(5):e48-e64. doi: 10.1093/cid/ciae433.
PubMed 39571607Durand ML, Barshak MB, Sobrin L. Eye Infections. N Engl J Med. 2023 Dec 21;389(25):2363-2375. doi: 10.1056/NEJMra2216081. No abstract available.
PubMed 38118024Ranjan R, Ranjan S. Ocular Pathology: Role of Emerging Viruses in the Asia-Pacific Region-A Review. Asia Pac J Ophthalmol (Phila). 2014 Sep-Oct;3(5):299-307. doi: 10.1097/APO.0000000000000021.
PubMed 26107917Tsui E, Sella R, Tham V, Kong AW, McClean E, Goren L, Bahar I, Cherian N, Ramirez J, Hughes RE Jr, Privratsky JK, Onclinx T, Feit-Leichman R, Cheng A, Molina I, Kim P, Yu C, Ruder K, Tan A, Chen C, Liu Y, Abraham T, Hinterwirth A, Zhong L, Porco TC, Lietman TM, Seitzman GD, Doan T; SCORPIO Study Group. Pathogen Surveillance for Acute Infectious Conjunctivitis. JAMA Ophthalmol. 2023 Dec 1;141(12):1140-1144. doi: 10.1001/jamaophthalmol.2023.4785.
PubMed 37917077Austin A, Lietman T, Rose-Nussbaumer J. Update on the Management of Infectious Keratitis. Ophthalmology. 2017 Nov;124(11):1678-1689. doi: 10.1016/j.ophtha.2017.05.012. Epub 2017 Sep 21.
PubMed 28942073Ai JW, Weng SS, Cheng Q, Cui P, Li YJ, Wu HL, Zhu YM, Xu B, Zhang WH. Human Endophthalmitis Caused By Pseudorabies Virus Infection, China, 2017. Emerg Infect Dis. 2018 Jun;24(6):1087-1090. doi: 10.3201/eid2406.171612.
PubMed 29774834Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.
PubMed 32015508Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7.
PubMed 30918369Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available.
PubMed 33607016
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Infectome Characterization of Eye Infections: a Metagenomic Sequencing Based Observational Study
- ClinicalTrials.gov ID
- NCT06775808
- Acronym / sponsor ID
- SHGH-CRU-2024516
- Conditions
- Eye Infections, Diagnosis
- Keywords
- infectome, metagenomic sequencing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Fourth People's Hospital Tongji University, The Central Hospital of Huanggang
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye infections cohort | – | –Patients diagnosed with on one or more type of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).
- Biological samples has been collected for clinical microbiological examination, or consented to participate in this study.
Key exclusion criteria (1 listed)
- 1. Patients who have no historically clinical surplus specimens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The pathogen profile
Time frame: through study completion, an average of 2 year
The bacteria, fungi, viruses, and parasites identified through metagenomic techniques in ocular samples.
1 secondary outcome
Microbial abundance
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 36757718Vasquez-Perez A, Magan T, Volpe G, Osborne SF, McFaul K, Vahdani K. Necrotizing Blepharoconjunctivitis and Keratitis in Human Monkeypox. JAMA Ophthalmol. 2023 Mar 1;141(3):285-288. doi: 10.1001/jamaophthalmol.2022.6253.
- Background: PubMed 36069833Rose-Nussbaumer J, Doan T. Role of Ophthalmology in Emerging Infectious Diseases. JAMA Ophthalmol. 2022 Oct 1;140(10):935. doi: 10.1001/jamaophthalmol.2022.4017.
- Background: PubMed 39571607Barshak MB, Durand ML, Gupta A, Mohareb AM, Dohlman TH, Papaliodis GN. State-of-the-Art Review: Ocular Infections. Clin Infect Dis. 2024 Nov 22;79(5):e48-e64. doi: 10.1093/cid/ciae433.
- Background: PubMed 38118024Durand ML, Barshak MB, Sobrin L. Eye Infections. N Engl J Med. 2023 Dec 21;389(25):2363-2375. doi: 10.1056/NEJMra2216081. No abstract available.
- Background: PubMed 26107917Ranjan R, Ranjan S. Ocular Pathology: Role of Emerging Viruses in the Asia-Pacific Region-A Review. Asia Pac J Ophthalmol (Phila). 2014 Sep-Oct;3(5):299-307. doi: 10.1097/APO.0000000000000021.
- Background: PubMed 37917077Tsui E, Sella R, Tham V, Kong AW, McClean E, Goren L, Bahar I, Cherian N, Ramirez J, Hughes RE Jr, Privratsky JK, Onclinx T, Feit-Leichman R, Cheng A, Molina I, Kim P, Yu C, Ruder K, Tan A, Chen C, Liu Y, Abraham T, Hinterwirth A, Zhong L, Porco TC, Lietman TM, Seitzman GD, Doan T; SCORPIO Study Group. Pathogen Surveillance for Acute Infectious Conjunctivitis. JAMA Ophthalmol. 2023 Dec 1;141(12):1140-1144. doi: 10.1001/jamaophthalmol.2023.4785.
- Background: PubMed 28942073Austin A, Lietman T, Rose-Nussbaumer J. Update on the Management of Infectious Keratitis. Ophthalmology. 2017 Nov;124(11):1678-1689. doi: 10.1016/j.ophtha.2017.05.012. Epub 2017 Sep 21.
- Background: PubMed 29774834Ai JW, Weng SS, Cheng Q, Cui P, Li YJ, Wu HL, Zhu YM, Xu B, Zhang WH. Human Endophthalmitis Caused By Pseudorabies Virus Infection, China, 2017. Emerg Infect Dis. 2018 Jun;24(6):1087-1090. doi: 10.3201/eid2406.171612.
- Background: PubMed 32015508Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3.
- Background: PubMed 30918369Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7.
- Background: PubMed 33607016Burton MJ, Ramke J, Marques AP, Bourne RRA, Congdon N, Jones I, Ah Tong BAM, Arunga S, Bachani D, Bascaran C, Bastawrous A, Blanchet K, Braithwaite T, Buchan JC, Cairns J, Cama A, Chagunda M, Chuluunkhuu C, Cooper A, Crofts-Lawrence J, Dean WH, Denniston AK, Ehrlich JR, Emerson PM, Evans JR, Frick KD, Friedman DS, Furtado JM, Gichangi MM, Gichuhi S, Gilbert SS, Gurung R, Habtamu E, Holland P, Jonas JB, Keane PA, Keay L, Khanna RC, Khaw PT, Kuper H, Kyari F, Lansingh VC, Mactaggart I, Mafwiri MM, Mathenge W, McCormick I, Morjaria P, Mowatt L, Muirhead D, Murthy GVS, Mwangi N, Patel DB, Peto T, Qureshi BM, Salomao SR, Sarah V, Shilio BR, Solomon AW, Swenor BK, Taylor HR, Wang N, Webson A, West SK, Wong TY, Wormald R, Yasmin S, Yusufu M, Silva JC, Resnikoff S, Ravilla T, Gilbert CE, Foster A, Faal HB. The Lancet Global Health Commission on Global Eye Health: vision beyond 2020. Lancet Glob Health. 2021 Apr;9(4):e489-e551. doi: 10.1016/S2214-109X(20)30488-5. Epub 2021 Feb 16. No abstract available.
- Individual participant dataSharing planned: No. IPD could be available on request to the principle investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuo Su, PhD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Infections and Diagnosis, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Kang, MPH (021-36126064, mei.kang@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pathogen profile (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775808, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.