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

NCT02151240 | Completed Phase 4 DMC

• 1 other identifier: cttq-focus-101
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Herpes Zoster

Keywords

herpes zoster, Foscarnet Sodium, Acyclovir, Postherpetic neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Postherpetic neuralgia

  3rd month

• number of participants with adverse event and serious adverse event

  up to 3 months

Study Arms (2)

Arm I

EXPERIMENTAL

Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV; Second administration: Foscarnet Sodium and Sodium Chloride Injection 3g: 250ml, IV

Drug: Foscarnet Sodium

Arm II

ACTIVE COMPARATOR

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

Interventions

Foscarnet Sodium DRUG

Arm I

Acyclovir DRUG

Arm II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cttq: lead
• Peking University People's Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related 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. doi: 10.1086/515045.

  PMID: 9868672 RESULT

• 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. doi: 10.7326/0003-4819-115-1-19.

  PMID: 1646585 RESULT

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Foscarnet; Acyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2019
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

CN (1)