Aim: NICHD-2012-AMP01 study was designed to characterize the pharmacokinetics (PK) and safety of ampicillin administered to infants per standard of care to address gap in pediatric labeling. Methods: The PK analysis include ampicillin data from NICHD-2011-POP01 study. The safety analysis includes ampicillin data from 1) NICHD-2011-POP01 study 2) Pediatric Pharmacology Research Unit (PPRU) study and 3) Pediatrix Medical Group Database. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. From the Pediatrix database Adverse events during ampicillin exposure were uncommon. Shorter dosing intervals were associated with more frequent hematologic AEs for infants of all age groups.

Contents

• 2. SYNOPSIS
• 4. GLOSSARY OF ABBREVIATIONS AND TERMS
• 5. ETHICS
  • 5.1. Institutional Review Board (IRB)
  • 5.2. Ethical Conduct of the Study
  • 5.3. Patient Information, Consent, and Assent
• 6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
  • 6.1. Principal Investigators
  • 6.2. Administrative Structure
• 7. INTRODUCTION
  • 7.1. Ampicillin Therapy for Bacterial Sepsis in Infants
  • 7.2. Ampicillin PK and Safety in Infants
  • 7.3. Opportunistic Studies in Children
  • 7.4. Premature Infant PK Studies
  • 7.5. BPCA Drug Prioritization
  • 7.6. Data Sources
  • 7.7. Structure for this Clinical Study Report
• 8. STUDY OBJECTIVES
• 9. INVESTIGATIONAL PLAN: NICHD-2011-POP01
  • 9.1. Overall Study Design and Plan Description
  • 9.2. Discussion of Study Design
  • 9.3. Study Population
  • 9.4. Treatments
  • 9.5. Pharmacokinetic and Safety Variables
  • 9.6. Biological Sample Analysis
  • 9.7. Data Quality Assurance
  • 9.8. Statistical Methods and Determination of Sample Size
  • 9.9. Changes in the conduct of the Study or the Planned Analyses
• 10. STUDY PATIENTS – NICHD-2011-POP01 STUDY
  • 10.1. Disposition of Participants
  • 10.2. Protocol Deviations and Waivers
• 11. PHARMACOKINETIC EVALUATION
  • 11.1. Data Sets Analyzed
  • 11.2. Summary of Demography, Dosing, and Data of Special Interest for Overall Study Population
  • 11.3. Measurement of Treatment Compliance
  • 11.4. Summary of PK Analysis
  • 11.5. PK and Surrogate PD Conclusions
• 12. SAFETY EVALUATION
  • 12.1. NICHD-2011-POP01
  • 12.2. PPRU Safety Analysis
  • 12.3. Pediatrix Safety Analysis
  • 12.4. Safety Conclusions
• 13. DISCUSSION AND OVERALL CONCLUSIONS
  • 13.1. Discussion
  • 13.2. Overall Conclusions
• 14. TABLES REFERRED TO BUT NOT INCLUDED IN THE TEXT
  • 14.1. Study Disposition, Baseline Participant Characteristics, and Protocol Deviation Summary Tables (NICHD-2011-POP01)
  • 14.2. Dosing and PK Collection Summary Tables (NICHD-2011-POP01)
  • 14.3. Safety Tables (NICHD-2011-POP01)
• 15. REFERENCE LIST
• 16. APPENDICES

Study data is available on the DASH repository at https://dash.nichd.nih.gov/study/20222

This study was conducted in compliance with Good Clinical Practices (GCP) as outlined in the International Conference on Harmonization (ICH), including the archiving of essential documents.

All unpublished information contained within this report is confidential and the sole property of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.