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

NCT02688790 | Terminated Phase 1 FDA Drug

• 1 other identifier: DAL-PK-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Bacterial Infections

Keywords

Dalbavancin; DALVANCE®; Suspected or Confirmed Bacterial Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

One dose of intravenous dalbavancin infusion 22.5 mg/kg in young infants aged greater than 28 days to 3 months

Drug: Dalbavancin

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Interventions

Dalbavancin DRUG

Also known as: Dalvance®

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• \. 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (5)

Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

University of California, San Diego

San Diego, California, 92123, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Todd Riccobene

  Allergan, plc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: April 1, 2016
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

US (5)