The goal of this clinical trial is to investigate the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients and is being conducted to collect pharmacokinetic (PK) and safety data to enable the identification of appropriate pediatric dosing regimens for patients with Acinetobacter baumannii-calcoaceticus complex (ABC) infections
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
25mg/kg SUL and 25mg/kg DUR
20mg/kg SUL and 20mg/kg DUR
25mg/kg SUL and 25mg/kg DUR
UCLA Medical Center
Los Angeles, California, United States
RECRUITINGRady Children's Hospital
San Diego, California, United States
RECRUITINGECU Brody School of Medicine
Greenville, North Carolina, United States
RECRUITINGAssess the pharmacokinetic (PK) parameters for maximum concentration (Cmax) of sulbactam and durlobactam
Time frame: Day 1 and Day 3
Assess the PK parameters for area under the plasma concentration-time curve from 0 to 24 hours (AUC 0-24) of sulbactam and durlobactam
Time frame: Day 1 and Day 3
Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Defined as any adverse event occurring after exposure to the study drug or any AE that worsens in intensity or frequency
Time frame: 28 days
Percentage of TEAEs leading to study drug discontinuation
Time frame: 28 days
Incidence of related TEAEs
Time frame: 28 days
Incidence of serious TEAEs
Time frame: 28 days
Change from baseline values of liver function measured by Comprehensive Metabolic Panel (CMP)
Time frame: Baseline and Day 28
Change from baseline values of kidney function measured by CMP
Time frame: Baseline and Day 28
Change from baseline values of hemoglobin
Time frame: Baseline and Day 28
Change from baseline value of white blood cell count
Time frame: Baseline and Day 28
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20mg/kg SUL and 20mg/kg DUR
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
RECRUITINGChange from baseline value of platelets
Time frame: Baseline and Day 28
Change from baseline value of diastolic blood pressure
Time frame: Baseline and Day 28
Change from baseline value of systolic blood pressure
Time frame: Baseline and Day 28
Change from baseline values of heart rate
Time frame: Baseline and Day 28
Change from baseline value of respiration rate
Time frame: Baseline through Day 28
Change from baseline value of temperature
Time frame: Baseline and Day 28