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

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.

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.