Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections

Inclusion Criteria:

• Males and females <18 years of age

• Neonates must be at least 34 weeks post-conception age

• Parent or legal guardian has given informed consent, as appropriate; and pediatricpatient has given verbal assent where appropriate.

• Suspected or diagnosed Gram positive bacterial infection for which the subject isreceiving standard antibiotic therapy; or peri-operative prophylactic use ofantibiotics

• Intravenous access to administer study drug

• The subject will be observed in the emergency room or hospital for at least 1 hourafter the study drug infusion is completed.

Exclusion Criteria:

• Septic shock or acute haemodynamic instability.

• History of immune-related hypersensitivity reaction to glycopeptides (such asvancomycin, dalbavancin, televancin, or teicoplanin) or any of their excipients.

• Subjects who have taken vancomycin, telavancin, teicoplanin or other glycopeptidewithin 24 hours of screening or who are anticipated to need these drugs within 48hours after administration of study drug. Subjects who have taken dalbavancin areexcluded if taken within the previous 2 weeks or who are anticipated to needdalbavancin within 48 hours after administration of study drug.

• Females who are of childbearing potential and unwilling to practice abstinence oruse at least two methods of contraception or female patients of childbearing who arelactating or have a positive pregnancy test result at screening

• Males who are unwilling to practice abstinence or use an acceptable method of birthcontrol during the entire study period

• Any surgical or medical condition which, in the opinion of the investigator, wouldput the patient at increased risk or is likely to interfere with study procedures orPK of the study drug.

• Patients whom the investigator considers unlikely to adhere to the protocol, complywith study drug administration, or complete the clinical study

• Treatment with investigational medicinal product or investigational device within 30days (or 5 times the half-life of the investigational medicine, whichever is longer)before enrollment and for the duration of the study.

• Any clinically significant disease or condition affecting a major organ system,including but not limited to gastrointestinal, renal, hepatic, endocrinologic,broncho-pulmonary, neurological, metabolic or cardiovascular disease.