Clinical trial NCT01946568: A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections.
Lead sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2013-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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.

Primary outcomes:
measure: To characterize the pharmacokinetics in pediatric patients by measuring AUC 0-inf of dalbavancin.
timeFrame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
measure: To characterize the pharmacokinetics in pediatric patients by measuring Cmax of dalbavancin.
timeFrame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
measure: To characterize the pharmacokinetics in pediatric patients by measuring AUC0-last of dalbavancin.
timeFrame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
measure: To characterize the pharmacokinetics in pediatric patients by measuring AUC0-t of dalbavancin.
timeFrame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
measure: To characterize the pharmacokinetics in pediatric patients by measuring Tmax of dalbavancin.
timeFrame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
measure: To characterize the pharmacokinetics in pediatric patients by measuring t1/2 of dalbavancin.
timeFrame: At 0.5 hours, 4 hours, 12 hours, 24 hours,144 hours and 648 hours post-dose.
Secondary outcomes:
measure: To evaluate the safety of a single dose of dalbavancin which will be measured by adverse event monitoring.
timeFrame: one year
measure: To evaluate the safety of a single dose of dalbavancin which will be measured by clinical laboratories (hematology and serum chemistry).
timeFrame: one year
measure: To evaluate the safety of a single dose of dalbavancin which will be measured by blood pressure and pulse rate.
timeFrame: one year
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University Arkansas Medical Center
state: Arkansas
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Hartford
country: United States
facility: Connecicut Children's Hospital
state: Connecticut
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Toledo
country: United States
facility: Pediatric Pharmacology
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital - Clinical Care Center
state: Texas
city: Tallinn
country: Estonia
facility: Tallin's Children Hospital Pediatric Clinic
city: Tartu
country: Estonia
facility: Tartu University Hospital Anesthesiology & Intensive Care
Study officials:
affiliation: Durata Therapeutics
name: Michael Dunne, MD
role: STUDY_DIRECTOR
References: