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

Herpes Zoster Clinical Trial

— Focus-101  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151240
• Other study ID #: cttq-focus-101
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: July 2019

Study information

• Verified date: June 2021
• Source: Cttq
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2019
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

1. Patients with history of allergy to Foscarnet Sodium or Acyclovir;

2. Other combined infection (bacteria, fungi)

3. Severe decline in immune function, or long-term use of corticosteroid and immunosuppressor

4. 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)

5. Women who are pregnant or lactating, and women of childbearing potential failed to use an adequate method of contraception to avoid pregnancy;

6. Patients using other antiviral drugs;

7. Long-term use of non-steroid anti-inflammatory drug, tricyclic antidepressant, anti-epileptic drugs or analgesic

8. Current malignant tumor;

9. Patients investigators consider as inappropriate to participate in the study

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Drug:
• Foscarnet Sodium

• Acyclovir

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cttq	Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Breton G, Fillet AM, Katlama C, Bricaire F, Caumes E. Acyclovir-resistant herpes zoster in human immunodeficiency virus-infected patients: results of foscarnet therapy. Clin Infect Dis. 1998 Dec;27(6):1525-7. — View Citation

Safrin S, Berger TG, Gilson I, Wolfe PR, Wofsy CB, Mills J, Biron KK. Foscarnet therapy in five patients with AIDS and acyclovir-resistant varicella-zoster virus infection. Ann Intern Med. 1991 Jul 1;115(1):19-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Postherpetic neuralgia		3rd month
Secondary	number of participants with adverse event and serious adverse event		up to 3 months