Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection

Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months With Suspected or Confirmed Bacterial Infection

The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.

Study Overview

• Status: Terminated
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Dalbavancin

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • University of California, San Diego
    • San Diego, California, United States, 92123
      • Mary Birch Hospital for Women and Newborns
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized male and female patients who are preterm neonates (gestational age

  ≥32 to <37 weeks, aged ≤28 days), term neonates (gestational age ≥37 weeks, aged ≤28 days) or young infants (aged 28 days to 3 months inclusive) who will be receiving at least 24 hours of appropriate non-investigational intravenous antiinfective treatment other than glycopeptide antibiotics for known or suspected bacterial infections. Patients with urinary tract infections due to Gram-positive organisms may be enrolled

• Each patient's parent(s)/legal guardian(s) must be willing and able to provide a signed and dated written informed consent document indicating that they have been informed of all pertinent aspects of the trial
• Each patient's parent(s)/legal guardian(s) must be willing and able, if patient is discharged from the hospital, to return the patient to the hospital or a designated clinic for scheduled visits, or allow a nurse to come to the patient's home for laboratory tests, PK and other out-patient procedures as required by the protocol
• Patients must be expected to survive with appropriate antibiotic therapy and appropriate supportive care throughout the study
• Sufficient intravenous access (peripheral or central) to receive Investigational Product (IP)
• Patients must have an audiologic assessment within 7 days prior to the investigational product infusion consisting of ear specific hearing testing utilizing distortion product evoked otoacoustic emissions,

Exclusion Criteria:

• 1. Treatment with an investigational drug within 30 days preceding the dose of IP
• Patients who are currently receiving intravenous vancomycin or other glycopeptide antibiotics. Dalbavancin may be administered 8 hours after the last dose of vancomycin. Vancomycin or other glycopeptide antibiotics should not be given during the 7 day period following administration of dalbavancin. If intravenous vancomycin or other glycopeptide use is unavoidable during the 7 day period following administration of dalbavancin, this should be documented as a concomitant medication
• Have aspartate aminotransferase (AST), alanine transaminase (ALT) or total bilirubin level > 3 times upper limit of normal (neonates with elevated total bilirubin could participate if conjugated bilirubin was normal)
• Albumin < half lower limit of normal
• Have received a blood or blood component (eg, red blood cells, fresh frozen plasma, platelets) transfusion during the 24-hour period before dosing
• Have any condition (eg. Septic shock, burns, cystic fibrosis, acute hemodynamic instability including those conditions requiring pressor support) that would make the patient, in the opinion of the Investigator, unsuitable for the study (eg, would place the patient at risk, compromise the quality of the data; or interfere with the absorption, distribution, metabolism or excretion of dalbavancin)
• Patients known to have hypersensitivity to glycopeptides
• Moderate or severe renal impairment defined as serum creatinine ≥2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis)
• Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; One dose of intravenous dalbavancin infusion 22.5 mg/kg in young infants aged greater than 28 days to 3 months	Drug: Dalbavancin; Other Names: Dalvance®
Experimental: Cohort 2; One dose of intravenous dalbavancin infusion 22.5 mg/kg in term neonates (defined as gestational age at or greater than 37 weeks) aged up to 28 days	Drug: Dalbavancin; Other Names: Dalvance®
Experimental: Cohort 3; One dose of intravenous dalbavancin infusion 22.5 mg/kg in preterm neonates (defined as gestational age of 32 weeks, up to 37 weeks) aged no more than 28 days	Drug: Dalbavancin; Other Names: Dalvance®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of dalbavancin	Day 1, Day 2, Day 5-9 and Day 24-32
Number of patients experiencing a treatment emergent adverse event	Baseline (Day 1) up to Day 35

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma drug concentration (Cmax)	Day 1, Day 2, Day 5-9 and Day 24-32
Area under the plasma concentration versus time curve (AUC)	Day 1, Day 2, Day 5-9 and Day 24-32
Apparent total body clearance (CL) of drug from plasma	Day 1, Day 2, Day 5-9 and Day 24-32
Apparent volume of distribution volume of distribution (V)	Day 1, Day 2, Day 5-9 and Day 24-32
Terminal elimination half-life (T1/2).	Day 1, Day 2, Day 5-9 and Day 24-32

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Todd Riccobene, Allergan, plc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Dalbavancin; DALVANCE®; Suspected or Confirmed Bacterial Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: DAL-PK-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No