Clinical Trial Search

Primary: Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population — 84.1; 79.9…

Primary: Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate — 48; 28…

Primary: Early Clinical Response — 306; 303 Participants

Primary: Number of Participants With a Clinical Cure — 45; 42 Participants — p=0.71

Primary: Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population. — 89.5; 88.2; 92.9; 92.7 percentage of…

Primary: Number of Participants With Abscess Resolution — 11; 9 Participants

Primary: Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements…

Primary: Satisfaction of Discharge Criteria — 15; 14 participants

Primary: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population — 74; 72; 3; 5 participants — p=0.5318

Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 36.1; 36.8; 23.3; 18.4 percentage of participants

Primary: Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population — 457; 487; 182; 187 participants

Primary: Clinical Response — 323; 321; 52; 58 participants

Primary: Clinical Response — 358; 364; 59; 57 patients

Primary: Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set — 396; 202; 58; 34 Participant

Primary: Recurrence Rates of Abscesses — 4; 14 participants

Primary: Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population — 61; 27; 4; 3 Participants

Primary: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population — 66; 66; 6; 3 participants — p=0.5289

Primary: Clinical Improvement at 7 Days After Incision and Drainage — 10; 14 participants

Primary: Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population — 75; 59; 9; 19 participants

Primary: Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE) — 49; 20; 1; 1 Participants

Primary: Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day — 43305; 40156; 43927; 30287 Extended-Spectrum Days-of-Therapy

Primary: Skin Swab and Culture With Colony Forming Units (CFUs) — 39; 51; 35; 22 negative skin cultures — p=0.68

Primary: Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline — 72; 35 Participants

Primary: Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population — 88.6; 89.6 percentage of…

Primary: Objective Response at 48 to 72 Hours (FDA Primary Endpoint) — 259; 266; 72; 63 Participants

Primary: Skin Abscess Resolution — 4; 3 participants

Primary: Early Clinical Efficacy — 285; 288; 86; 80 participants

Primary: Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up — 57; 50; 53 Participants

Primary: Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit — 2; 1; 0; 0 Participants

Primary: Number of Infection-related Total Admitted Hospital Days — 4.8; 3.2 Days — p=0.003