Total Infectome Characterization of Eye Infections

NCT06775808 | Recruiting

• 1 other identifier: SHGH-CRU-2024516
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Infections; Diagnosis

Keywords

infectome; metagenomic sequencing

Outcome Measures

Primary Outcomes (1)

• The pathogen profile

  The bacteria, fungi, viruses, and parasites identified through metagenomic techniques in ocular samples.

  through study completion, an average of 2 year

Secondary Outcomes (1)

• Microbial abundance

  through study completion, an average of 2 year

Study Arms (1)

Eye infections cohort

Patients diagnosed with on one or more type of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with one or more types of eye infections (including acute conjunctivitis, keratitis, uveitis, and endophthalmitis).

You may qualify if:

• 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.

You may not qualify if:

• \. Patients who have no historically clinical surplus specimens.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Fourth People's Hospital Tongji University: collaborator
• The Central Hospital of Huanggang: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 36757718 BACKGROUND

• Rose-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.

  PMID: 36069833 BACKGROUND

• Barshak 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.

  PMID: 39571607 BACKGROUND

• Durand 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.

  PMID: 38118024 BACKGROUND

• Ranjan 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.

  PMID: 26107917 BACKGROUND

• Tsui 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.

  PMID: 37917077 BACKGROUND

• Austin 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.

  PMID: 28942073 BACKGROUND

• Ai 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.

  PMID: 29774834 BACKGROUND

• Wu 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.

  PMID: 32015508 BACKGROUND

• Chiu CY, Miller SA. Clinical metagenomics. Nat Rev Genet. 2019 Jun;20(6):341-355. doi: 10.1038/s41576-019-0113-7.

  PMID: 30918369 BACKGROUND

• Burton 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.

  PMID: 33607016 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Conjunctival sac swabs (1 swab for each involving eye), intraocular fluid (more than 100μl).

MeSH Terms

Conditions

Eye Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shuo Su, PhD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Mei Kang, MPH

CONTACT

021-36126064; mei.kang@shgh.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 15, 2025
• Study Start: December 25, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)