Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Abscess; Wound Infection; Surgical Site Infection; Cellulitis
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Cellulitis
Intervention: Dalbavancin; Dalbavancin-matching Placebo
Intervention description: Dalbavancin IV infusion over 30 minutes.; Dalbavancin-matching placebo IV infusion over 30 minutes.
Intervention MeSH terms: Dalbavancin; Teicoplanin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 698.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment
      with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in
      participants with known or suspected Gram-positive acute bacterial skin and skin structure
      infections (ABSSSI) at 48 -72 hours after initiation of treatment.
    

Eligibility criteria:

        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 cellulitis
             suspected or confirmed to be caused by Gram-positive bacteria.

          -  At least two (2) local signs and symptoms of acute bacterial skin and skin structure
             infection (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-positive
             spectrum that achieves therapeutic concentrations in the serum or at the site of the
             ABSSSI within 14 days prior to randomization. An exception is allowed for participants
             receiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug
             prior 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 dalbavancin
             or vancomycin (vancomycin MIC (minimum inhibitory concentration) >8 μg/mL).

          -  Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic
             arthritis, osteomyelitis; endovascular infection, such as clinical and/or
             echocardiographic evidence of endocarditis or septic thrombophlebitis.

          -  Infections caused exclusively by Gram-negative bacteria (without Gram-positive
             bacteria present) and infections caused by fungi, whether alone or in combination with
             a bacterial pathogen.

          -  Venous catheter entry site infection.

          -  Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus
             ulcer.

          -  Participant with an infected device, even if the device is removed. Examples include
             infection 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 dialysis
             catheter, 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 or
             Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the
             study, or is subsequently found to have been present at Baseline, the participant
             should be removed from study treatment and receive appropriate antibiotic(s) to treat
             the Gram-negative bacteremia. Such participants must have an end of treatment (EOT)
             visit performed within 3 calendar days after discontinuing study medication but are
             required to have AEs (adverse events) reported through the Final Visit.

          -  Participants whose ABSSSI is the result of having sustained full or partial thickness
             burns.

          -  Participants with an infection involving a limb with evidence of critical ischemia of
             an affected limb defined as any of the following criteria: absent or abnormal Doppler
             wave forms, toe blood pressure of <45 mm Hg, ankle brachial index <0.5, and/ or
             critical 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 drainage
             for cure.

          -  Concomitant condition requiring any antibiotic therapy that would interfere with the
             assessment 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 the
             ABSSSI.

          -  More than 2 surgical interventions (defined as procedures conducted under sterile
             technique and typically unable to be performed at the bedside) for the ABSSSI, or
             participants who are expected to require more than 2 such interventions.

          -  Medical conditions in which chronic inflammation may preclude assessment of clinical
             response to therapy even after successful treatment (e.g., chronic stasis dermatitis
             of 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 current
             acquired 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) or
             receiving immunosuppressant drugs after organ transplantation.

          -  Participants with a rapidly fatal illness, who are not expected to survive for 3
             months.

          -  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 participants
             inappropriate for entry into this study.

          -  Prior participation in this study.