This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to \<18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study.
This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of IV eravacycline in children with suspected or confirmed bacterial infection who are receiving systemic antibiotic therapy, other than eravacycline. The study design will allow for evaluation of PK and safety of IV eravacycline in a pediatric population at exposures predicted to be comparable to those already studied in adults. The study design is depicted in Figure 1. Two cohorts defined by age group will be enrolled simultaneously: * Cohort 1: 12 to \<18 years of age (adolescents) * Cohort 2: 8 to \<12 years of age (younger children) Eravacycline will be administered as a single IV dose using the optimum dosage determined from PK-PD modeling and model-based simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK analysis at predetermined timepoints.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Subjects will be stratified by age into 2 cohorts, as follows: * Cohort 1: from 12 to \<18 years of age (N=8) * Cohort 2: from 8 to \<12 years of age (N=12 or at least 60% of subjects)
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Tufts Medical Center
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration
Cmax, maximum observed plasma concentration
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve
AUC0-t, area under the plasma concentration
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life
t1/2, elimination half-life
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration
Clast, last observed plasma concentration
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
CL, systemic clearance
Time frame: Screening (-2 to 1) to Day 7
Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution
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Boston, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Vd, volume of distribution
Time frame: Screening (-2 to 1) to Day 7
Adverse Events
Assess Adverse Events to assess safety and tolerability
Time frame: From the time of signing the informed consent form to Day 7
A Directed Physical examination including chest/respiratory
Changes in Physical examination findings including chest/respiratory
Time frame: Screening (-2 to 1) to Day 7.
A Directed Physical examination including heart/cardiovascular
Changes in Physical examination findings including heart/cardiovascular
Time frame: Screening (-2 to 1) to Day 7.
Vital Signs including blood pressure
Changes in blood pressure
Time frame: Screening (-2 to 1) to Day 7
Vital Signs including heart rate
Changes in heart rate
Time frame: Screening (-2 to 1) to Day 7
Vital Signs including respiratory rate
Changes in respiratory rate
Time frame: Screening (-2 to 1) to Day 7
Vital Signs including body temperature
Changes in body temperature
Time frame: Screening (-2 to 1) to Day 7
Safety laboratory results including clinical chemistry
Changes in Clinical laboratory tests including clinical chemistry
Time frame: Screening (-2 to 1) to Day 7
Safety laboratory tests including hematology
Changes in Clinical laboratory tests including hematology
Time frame: Screening (-2 to 1) to Day 7