Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Foscarnet Sodium and Sodium Chloride Injection in patients with herpes zoster, and observe incidence of Postherpetic neuralgia

Official Title
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A Multi-centered, Randomized Study to Evaluate the Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection Compared to Intravenous Acyclovir in Patients With Herpes Zoster From China

Conditions
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Herpes Zoster

Intervention / Treatment
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* Drug: Foscarnet Sodium
* Drug: Acyclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Patients with clinical diagnosis of Herpes Zoster, and able to be enrolled into the study ≤ 72 hours from appearance of rash; 2.18-65 years old, men and women; 3.VAS score≥4; 4.Patients haven't receive any antiviral medication before enrollment; 5.Patients able to understand the study procedures, agree to participate and give written consent. Exclusion Criteria: Patients with history of allergy to Foscarnet Sodium or Acyclovir; Other combined infection (bacteria, fungi) Severe decline in immune function, or long-term use of corticosteroid and immunosuppressor Serious liver or renal function abnormalities (Aspartate Transaminase(AST) or alanine transaminase(ALT) ≥ 2.5x upper limits of normal(ULN), Creatinine(Cr) or Blood urea nitrogen(BUN)≥ 1x ULN) Women who are pregnant or lactating, and women of childbearing potential failed to use an adequate method of contraception to avoid pregnancy; Patients using other antiviral drugs; Long-term use of non-steroid anti-inflammatory drug, tricyclic antidepressant, anti-epileptic drugs or analgesic Current malignant tumor; Patients investigators consider as inappropriate to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV; Second administration: Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV | Drug: Foscarnet Sodium<br> <br> |
| Active Comparator: Arm II<br>First administration: Acyclovir for Injection 0.25g + 0.9% Sodium Chloride Injection 250ml, IV; Acyclovir for Injection 0.25g + 0.9% Sodium Chloride Injection 250ml, IV; Second administration: Acyclovir for Injection 0.25g+ 0.9% Sodium Chloride Injection 250ml, IV | Drug: Acyclovir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate | Effective rate = (No. of patients achieving recovery+ markedly improvement)/Total patients No.×100%. Recovery: curative index≥90%; Markedly improved: curative index 60%-89%; Improved: curative index 20%-59%; Ineffective: curative index<20%. Where Curative Index= (patient's pre-treatment condition score - post-treatment condition score)/pre-treatment condition score ×100% | 8th days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postherpetic neuralgia |  | 3rd month | 
| number of participants with adverse event and serious adverse event |  | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herpes zoster, Foscarnet Sodium, Acyclovir, Postherpetic neuralgia