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The efficacy and safety of foscarnet in the management of refractory herpes simplex virus keratitis: a prospective multicentric controlled study

The efficacy and safety of foscarnet in the management of refractory herpes simplex virus keratitis: a prospective multicentric controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044197
Enrollment
Unknown
Registered
2021-03-12
Start date
2021-03-08
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

herpes simplex virus keratitis

Interventions

observation group:Foscarnet ( IV.)
control group:acyclovir(IV.)

Sponsors

School of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 at the time of signing the informed consent (male or non-pregnant female); 2. Stromal keratitis was defined as an area at least 2.5mm2 of active stromal inflammation with diffuse or discform inflammatory stromal edema (non-necrotizing stromal keratitis) or dense, opaque, inflammatory infiltration (necrotizing stromal keratitis). 3. Has met one of the following 2 medical histories: A. Has been treated with an adequate therapeutic dose of antiviral drugs (specifically, intravenous acyclovir 10mg/kg Q8h or intravenous ganciclovir 5mg/kg Q12h) for at least 5 days without significant improvement; B.Improve after treatment of an adequate therapeutic dose of intravenous antivirals for at least 5 days, and then worsen again within 2 weeks after switch to oral antiviral treatment; (4) The subjects can understand and sign the informed consent; (5) Subjects are willing and able to follow planned visits, treatment plans, laboratory tests, and other study procedures.

Exclusion criteria

Exclusion criteria: (1) Patients with severe hepatic and renal insufficiency (especially CCR < 0.8ml /min/kg);Or electrolyte disorders; (2) Severe heart disease, treatment of intolerance; (3) Complicated with definite immunodeficiency disease (4) Patients with neuroparesthesia or anemia, neutrophils or thrombocytopenia; (5) Pregnant and lactation patients, or all subjects of reproductive age (male and female) who planned to become pregnant or were unwilling to use contraception during the study period; (6) People with mental or mental illness; (7) People who are allergic to the drugs used; (8) According to the researcher's judgment, the subjects may have human rights systemic diseases that are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
effective rate;HSK cure time;

Countries

China

Contacts

Public ContactWei Chen

School of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical University

1300956353@qq.com+86 13757728118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026