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This is a phase III, multi-center, randomized, active-comparator, study in subjects with ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1 and IV subgroup 2. Each subgroup will comprise of two treatment arms.
Full description
Subjects willing to participate in the study and fulfilling all eligibility criteria will receive either oral therapy (subgroup 1) or IV therapy (subgroup 2). The investigator can initiate treatment with either oral or IV therapy based on clinical judgement i.e subjects who require IV therapy (like subjects with severe ABSSSI or where oral administration is not feasible).
Enrollment
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Inclusion criteria
Subjects must be willing to participate in the study and provide a written informed consent
Subjects with ABSSSI characterized by any of the following infection types:
Subjects with lesion size area of at-least 75 cm2. Lesion size will be measured by the area of redness, edema, or induration
Subjects with suspected and/or documented evidence of Gram-positive infection
Exclusion criteria
ABSSSI meeting any of the following criteria:
Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely)
ABSSSI expected to require more than 10 days of antimicrobial therapy as per the discretion of the Investigator
Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene
ABSSSI requiring surgical intervention (except surgical incision and drainage for abscess) 2. Subjects who have received prior antibiotic therapy within past 24 hours for the treatment of current episode of ABSSSI. Following are the exceptions to this criteria:
Primary purpose
Allocation
Interventional model
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501 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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