A Comparison of the Efficacy and Safety of Delafloxacin Versus Linezolid and Meropenem in Severe Skin Infections

INTERVENTION: Intervention1: Delafloxacin for Injection 300 mgvial and Delafloxacin Tablets 450 mg: Delafloxacin for Injection 300 mg vial will be administered as an approx. 1‐hour I.V. infusion every 12 hours plus minus 2 hours for 3 days (6 doses) with an option to switch to Delafloxacin Tablets 450 mg administered orally every 12 hours plus minus 2 hours for the remaining doses. Recommended treatment duration is 5 to 14 days Control Intervention1: Linezolid intravenous I.V. injection 600 mg and Linezolid Tablets 600 mg: IV Therapy with option to switch to oral therapy: Linezolid I.V. injection 600 mg administered as an approx. 30 to 120 minutes I.V. infusion every 12 hours plus minus 2 hours with an option to switch to Linezolid Tablets 600 mg administered orally every 12 hours plus minus 2 hours for the remaining doses. Recommended treatment duration is 10 to 14 days Control Intervention2: Meropenem Injection 500 mg or 1000 mg: Only for patients in whom Gram negative pathogen identified at Baseline culture or gram staining: In addition to Linezolid therapy, patients will be initiated on Meropenem therapy as below: Meropenem 500 mg every 8 hours plus minus 2 hours, administered as a 15 to 30 minutes IV infusion. Recommended treatment duration is 3 to 14 days. 1 gram every 8 hours plus minus 2 hours administered as a 15 to 30 minutes IV infusion is recommended when treating infections caused by P. aeruginosa. Recommended treatment duration is 3 to 14 days. CONDITION: Health Condition 1: L039‐ Cellulitis and acute lymphangitis,unspecified PRIMARY OUTCOME: Proportion of patients with Clinical Success on Objective Response Assessment ORATimepoint: Proportion of patients with Clinical Success on Objective Response Assessment ORA SECONDARY OUTCOME: All‐cause mortalityTimepoint: [Timeframe: LFU] Change from baseline in patients subjective assessment of pain on Numerical Rating ScaleTimepoint: [Timeframe: Baseline, EOT, TOC, LFU] Proportion of Microbiological RespondersTimepoint: [Timeframe: TOC] Proportion of patients with Adverse Events of Special Interest AESITimepoint: [Timeframe: Throughout study duration] Proportion of patients with Investigator Assessed Clinical CureTimepoint: [Timeframe: EOT, TOC, LFU] Proportion of patients with Investigator Assessed Clinical SuccessTimepoint: [Timeframe: EOT, TOC, LFU] Safety: ; 1. Number and proportion of patients with treatment emergent adverse events TEAEs and Serious Adverse Events ; Timepoint: [Timeframe: Throughout study duration] INCLUSION CRITERIA: 1. Patients of either gender with age between 18 to 65 years both inclusive and willing to provide written informed consent and comply with protocol requirements. 2. Patients with Severe Skin and Skin Structure Infection Acute Bacterial Skin and Skin Structure Infections, of at least 1 of the following 3 types: a. Cellulitis, erysipelas b. Wound infection c. Major cutaneous abscess 3. Patients should have at least 2 signs of systemic infection 4. Patients with at least one risk factor for Multi Drug Resistant MDR ABSSSI 5. Patients who have been diagnosed with Methicillin resistant Staphylococcus aureus MRSA positive ABSSSI on microbiological evaluation at randomization visit 6. Women of childbearing potential must have a negative urine pregnancy test prior to Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till