Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Inclusion Criteria:

• Male or female participants 18 - 85 years of age.

• Signed and dated informed consent document.

• Major abscess, surgical site infection, traumatic wound infection or cellulitissuspected or confirmed to be caused by Gram-positive bacteria.

• At least two (2) local signs and symptoms of acute bacterial skin and skin structureinfection (ABSSSI and at least one systemic sign of infection.

• Participant willing and able to comply with study procedures.

Exclusion Criteria:

• A contra-indication to dalbavancin.

• Pregnant or nursing females.

• Sustained shock.

• Participation in another study of an investigational drug or device within 30 days.

• Receipt of a systemically or topically administered antibiotic with a Gram-positivespectrum that achieves therapeutic concentrations in the serum or at the site of theABSSSI within 14 days prior to randomization. An exception is allowed for participantsreceiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drugprior to randomization; up to 25% of participants may have received such therapy.

• Infection due to an organism known prior to study entry to be resistant to dalbavancinor vancomycin (vancomycin MIC (minimum inhibitory concentration) >8 μg/mL).

• Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septicarthritis, osteomyelitis; endovascular infection, such as clinical and/orechocardiographic evidence of endocarditis or septic thrombophlebitis.

• Infections caused exclusively by Gram-negative bacteria (without Gram-positivebacteria present) and infections caused by fungi, whether alone or in combination witha bacterial pathogen.

• Venous catheter entry site infection.

• Infections involving a diabetic foot ulceration, perirectal abscess or a decubitusulcer.

• Participant with an infected device, even if the device is removed. Examples includeinfection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack,joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator,intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysiscatheter, or a neurosurgical device such as a ventricular peritoneal shunt,intra-cranial pressure monitor, or epidural catheter.

• Gram-negative bacteremia, even in the presence of Gram-positive infection orGram-positive bacteremia. Note: If a Gram-negative bacteremia develops during thestudy, or is subsequently found to have been present at Baseline, the participantshould be removed from study treatment and receive appropriate antibiotic(s) to treatthe Gram-negative bacteremia. Such participants must have an end of treatment (EOT)visit performed within 3 calendar days after discontinuing study medication but arerequired to have AEs (adverse events) reported through the Final Visit.

• Participants whose ABSSSI is the result of having sustained full or partial thicknessburns.

• Participants with an infection involving a limb with evidence of critical ischemia ofan affected limb defined as any of the following criteria: absent or abnormal Dopplerwave forms, toe blood pressure of <45 mm Hg, ankle brachial index <0.5, and/ orcritical ischemia as assessed by a vascular surgeon.

• Participants with ABSSSI such as superficial/simple cellulitis/erysipelas,impetiginous lesion, furuncle, or simple abscess that only requires surgical drainagefor cure.

• Concomitant condition requiring any antibiotic therapy that would interfere with theassessment of study drug for the condition under study.

• Anticipated need of antibiotic therapy for longer than 14 days.

• Participants who are placed in a hyperbaric chamber as adjunctive therapy for theABSSSI.

• More than 2 surgical interventions (defined as procedures conducted under steriletechnique and typically unable to be performed at the bedside) for the ABSSSI, orparticipants who are expected to require more than 2 such interventions.

• Medical conditions in which chronic inflammation may preclude assessment of clinicalresponse to therapy even after successful treatment (e.g., chronic stasis dermatitisof the lower extremity).

• Absolute neutrophil count <500 cells/mm^3.

• Known or suspected human immunodeficiency virus (HIV) infected participants with a CD4 (cluster of differentiation 4) cell count <200 cells/mm3 or with a past or currentacquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.

• Participants with a recent bone marrow transplant (in post-transplant hospital stay).

• Participants receiving oral steroids >20 mg prednisolone per day (or equivalent) orreceiving immunosuppressant drugs after organ transplantation.

• Participants with a rapidly fatal illness, who are not expected to survive for 3months.

• Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation orinvestigational product administration or may interfere with the interpretation ofstudy results and, in the judgment of the investigator, would make the participantsinappropriate for entry into this study.

• Prior participation in this study.