A multicenter, Single-arm trial to evaluate the efficacy and safety of trifluridine therapy for patients with conjunctivitis caused by mpox virus.

JRCT ID: jRCTs031240048

Registered date:25/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Conjunctivitis caused by Mpox virus
• Date of first enrollment: 01/06/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Starting 2 weeks: 1 drop in the affected eye every 2 hours while awake (maximum of 9 drops per eye per day).
Subsequent 1 week: 1 drop in the affected eye every 4 hours while awake (minimum 5 drops per day).

Outcome(s)

Primary Outcome

The primary endpoint is the sum of the scores obtained by evaluating the following items.
Eyelid skin findings: erythema, swelling, skin rash
Conjunctival findings: hyperemia of the bulbar conjunctiva, elevated lesions/ulcers, ocular grease
Corneal findings: superficial keratitis, infiltrates/ulcers, corneal opacity
Other findings: corneal perforation, endophthalmitis, ocular inflammation

• Secondary Outcome: Viral load of conjunctival swab 7, 14, 21, and 30 days after test inclusion

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

All of 1) to 2) must be met.
1) Who are 6 years of age or older at the time of obtaining consent.
2) Those who have been diagnosed with conjunctivitis caused by the Mpox virus. However, the diagnosis of empoxvirus shall be made when the pathogen is detected in conjunctival swab fluid by the following methods.
Direct observation of virus particles by electron microscopy
Detection of pathogens by separation and identification
Detection of pathogen antigens by fluorescent antibody method
Detection of pathogen genes by PCR

Exclude criteria

1) Patients who have had anaphylaxis or serious systemic reactions to trifluridine in the past
2) Persons deemed inappropriate for inclusion in the study by the principal investigator

Related Information

• Primary Sponsor: Morioka Shinichiro
• Secondary Sponsor: Ohmagari Norio,Expected to be secured from AMED or MHLW