A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.

NCT01946568 | Completed Phase 1

• 1 other identifier: DUR001-106
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 12

Brief Summary

A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

Conditions

Bacterial Infections.

Outcome Measures

Primary Outcomes (6)

• To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.

  To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

  At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

• To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin.

  To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

  At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

• To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.

  To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

  At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

• To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.

  To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

  At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

• To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin.

  To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

  At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

• To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin.

  To characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

  At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.

Secondary Outcomes (3)

• To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring.

  one year

• To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry).

  one year

• To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate.

  one year

Study Arms (1)

Single dose Dalbavancin

EXPERIMENTAL

Drug: Dalbavancin

Interventions

Dalbavancin DRUG

Intravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients \<5 years of age.

Single dose Dalbavancin

Eligibility Criteria

• Age: 3 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalized patients who will be receiving at least 24 hours of appropriate non-investigational intravenous anti-infective treatment for known or suspected bacterial infections with the exception of urinary tract infections.
• Written parental informed consent.
• Able to comply with the protocol for the duration of the study.
• Expected to survive throughout the study.
• Normal audiologic assessment within 3 days prior to the study drug infusion.

You may not qualify if:

• Investigational drug within 30 days or 5 half-lives, whichever is longest, preceding the first dose of study medication.
• History of fluctuant hearing, persistent tinnitus, balance disorder, otologic surgery or disease, tumor of the head, neck, or auditory system, head injury, Meniere's disease, autoimmune inner ear disease, perilymphatic fistula, CNS disorder resulting in hearing deficits, or significant noise exposure.
• Significant exposure to aminoglycoside antibiotics or chemotherapy currently or within a week prior to enrollment into the study or current use of loop diuretics.
• Patients continuing on vancomycin treatment or are anticipated to begin vancomycin or other glycopeptide treatment during the 7 day period after dalbavancin administration.
• Patients with any clinically significant abnormality other than that associated with their underlying disease. Aminotransferases (AST, ALT) \>5 x ULN; total bilirubin and alkaline phosphatase) \>2 x ULN.
• Albumin \< half lower limit of normal or physical exam evidence of malnutrition.
• Patients who are less than one year of age, and were born with gestational age of less than 32 weeks.
• Positive urine (or serum) pregnancy test at screening (post menarchal females only) or after admission (prior to dosing).
• Known to have hypersensitivity to glycopeptides.
• Calculated creatinine clearance \<30 ml/min using the Schwartz method.
• Pregnant or nursing females.
• Other severe acute or chronic medical or psychiatric 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

• Durata Therapeutics Inc., an affiliate of Allergan plc: lead

Study Sites (12)

University Arkansas Medical Center

Little Rock, Arkansas, 72202, United States

Location

University of California, San Diego

San Diego, California, 92123, United States

Location

Connecicut Children's Hospital

Hartford, Connecticut, 06106, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Pediatric Pharmacology

Toledo, Ohio, 43606, United States

Location

Texas Children's Hospital - Clinical Care Center

Houston, Texas, 77030, United States

Location

Tallin's Children Hospital Pediatric Clinic

Tallinn, 13419, Estonia

Location

Tartu University Hospital Anesthesiology & Intensive Care

Tartu, 51015, Estonia

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Michael Dunne, MD

  Durata Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 19, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (10); ES (2)