Trial record 7 of 690 for:    Open Studies | "Bacterial Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Durata Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01946568
First received: August 29, 2013
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Bacterial Infections.
Drug: Dalbavancin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety and Tolerability Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections

Resource links provided by NLM:


Further study details as provided by Durata Therapeutics, Inc.:

Primary Outcome Measures:
  • To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin. [ Time Frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. ] [ Designated as safety issue: No ]
    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.

  • To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin. [ Time Frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. ] [ Designated as safety issue: No ]
    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.

  • To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin. [ Time Frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. ] [ Designated as safety issue: No ]
    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.

  • To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin. [ Time Frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. ] [ Designated as safety issue: No ]
    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.

  • To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin. [ Time Frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. ] [ Designated as safety issue: No ]
    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.

  • To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin. [ Time Frame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry). [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single dose Dalbavancin Drug: Dalbavancin
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.

Detailed Description:

This is a open label, multi center study to investigate the pharmacokinetics, safety and tolerability of a single dose of intravenous dalbavancin in hospitalized pediatric patients with known or suspected bacterial infection. Patients will be enrolled and results will be evaluated in 3 age cohorts as follows:

Cohort 1: Patients 6 years to 11 years of age, inclusive; Cohort 2: Patients 2 years to <6 years of age; Cohort 3: Patients 3 months to <2 years of age.

All patients in each cohort will be administered a single dose of dalbavancin in addition to background anti infective treatment to be chosen by the investigator according to standard of care. Pharmacokinetic samples will be obtained at various timepoints. Dalbavancin can be administered at any time (before, during or after) the standard of care therapy.

  Eligibility

Ages Eligible for Study:   3 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946568

Contacts
Contact: Milan Kovacevic mkovacevic@duratatherapeutics.com

Locations
United States, Arkansas
University Arkansas Medical Center Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92123
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
United States, North Carolina
Duke Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Texas
Texas Children's Hospital - Clinical Care Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Durata Therapeutics, Inc.
Investigators
Study Director: Michael Dunne, MD Durata Therapeutics
  More Information

No publications provided

Responsible Party: Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01946568     History of Changes
Other Study ID Numbers: DUR001-106
Study First Received: August 29, 2013
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Dalbavancin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014