Safety and efficacy of high-dose Acyclovir in infants with HSV or suspected HSV / Phillip Brian Smith.

Format:

Book

Author/Creator:

Smith, Phillip Brian, author.

Language:

English

Subjects (All):

Herpes simplex virus.

Physical Description:

1 online resource

Place of Publication:

Bethesda, Maryland : National Institute of Child Health and Human Development, 2017.

Summary:

This study was an open-label evaluation of acyclovir for 21 days. A total of 88 infants who had been diagnosed with HSV infection were enrolled including 16 who received an intermediate dose (ID) (45 mg/kg/day) and 72 who received HD (60 mg/kg/day). Among those, 79 infants with virologically confirmed infection were included in the efficacy analysis. Clinical outcomes (neurodevelopment impairment, mortality and HSV recurrences) were assessed at up to 4 years of life. In infants with virologically confirmed infection and who received HD acyclovir (n=66), outcomes at 12 months of age were compared with the historical cohort who received SD acyclovir from the Whitley trial. The survival rate for infants treated with HD acyclovir was statistically significantly higher than for those treated with SD acyclovir (Odds Ratio: 3.3; 95% CI: 1.5 to 7.3). Recipients of HD acyclovir had a borderline significant decrease in morbidity compared with SD recipients, after adjusting for the extent of disease (SEM vs. CNS vs. disseminated), HSV type (1 vs. 2), prematurity, and disease severity (seizures).

Contents:

2. SYNOPSIS

4. GLOSSARY OF ABBREVIATIONS AND TERMS

5. ETHICS

5.1. Institutional Review Board

5.2. Ethical Conduct of the Study

5.3. Participant Information, Consent, and Assent

6. INVESTIGATOR AND STUDY ADMINISTRATIVE STRUCTURE

6.1. Principal Investigator

6.2. Administrative Structure

7. INTRODUCTION

Pharmacodynamics Endpoint

7.1. Data Sources for This Report

7.2. Structure for this Clinical Study Report

8. STUDY OBJECTIVES

9. INVESTIGATIONAL PLAN

9.1. Overall Design and Plan Description

9.2. Discussion of Study Design and Choice of Control Groups

9.3. Selection of Study Population

9.4. Treatments

9.5. Efficacy and Safety Variables

9.6. Data Quality Assurance

9.7. Statistical Methods and Determination of Sample Size

9.8. Changes in the Conduct of the Study or the Planned Analyses

10. STUDY PARTICIPANTS

10.1. Disposition of Participants - Pediatrix Medical Group Database

10.2. Disposition of Participants - Medical Chart Review

11. EFFICACY EVALUATION

12. SAFETY EVALUATION

12.1. Pediatrix Administrative Database Safety Analysis

12.2. Medical Chart Review

12.3. Safety Conclusions

13. DISCUSSION AND OVERALL CONCLUSIONS

13.1. Overall Conclusions

14. TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE TEXT

14.1. Demographic Data

14.2. Safety Data

14.3. Dosing Data

15. REFERENCE LIST

16. APPENDICES

Descriptive Supplementary Documents.

Notes:

Description based on online resource; title from PDF title page (National Institute of Child Health and Human Development, viewed April 20, 2023).