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

Completed · Phase 1

Conditions studied: Bacterial Infections.

In brief

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.

Key facts

Study ID

NCT01946568

Run by

Durata Therapeutics Inc., an affiliate of Allergan plc

People needed

36

Starts

2013-06-01

Expected to finish

2015-04-01

Last updated by the study team

2015-06-23

Who can join

Age: 0 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University Arkansas Medical Center — Little Rock, Arkansas, United States
• University of California, San Diego — San Diego, California, United States
• Connecicut Children's Hospital — Hartford, Connecticut, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Columbia University — New York, New York, United States
• Duke Medical Center — Durham, North Carolina, United States
• Pediatric Pharmacology — Toledo, Ohio, United States
• Texas Children's Hospital - Clinical Care Center — Houston, Texas, United States
• Tallin's Children Hospital Pediatric Clinic — Tallinn, Estonia
• Tartu University Hospital Anesthesiology & Intensive Care — Tartu, Estonia

Full record on ClinicalTrials.gov

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