Health Condition 1: null- Adult subjects diagnosed with Acute Bacterial Skin and Skin Structure Infections suspected to be caused by Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) Health Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: IV WCK 771 and oral WCK 2349: oral WCK 2349- 1000 mg BID
IV WCK 771-800 mg BID
Control Intervention1: IV Linezolid
oral linezolid: IV Linezolid- 600 mg
oral linezolid- 600 mg
Sponsors
Wockhardt BioAg
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with ABSSSI characterized by any of the following infection types: a. Cellulitis/erysipelas: diffuse skin infection characterized by spreading areas of redness, edema, and/or induration b. Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration c. Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that is accompanied by redness, edema, and/or induration 2. Subjects with suspected and/or documented evidence of Gram-positive infection
Exclusion criteria
Exclusion criteria: 1.ABSSSI expected to require more than 10 days of antimicrobial therapy as per the discretion of the Investigator 2. Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene 3. ABSSSI requiring surgical intervention (except surgical incision and drainage for abscess) 4. Subjects who have received prior antibiotic therapy within past 24 hours for the treatment of current episode of ABSSSI. 5. Subjects with current history or diagnosis of HIV, positive test result for hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) 6. Subjects with any clinically significant abnormalities in pulmonary,gastrointestinal, endocrine, hepatic or renal systems Subjects with history of hypersensitivity to any of the study drugs or same class of drugs 7. Subjects who have received any monoamine oxidase inhibitors within 2 weeks prior to enrolment 8. Subjects with neoplastic disorder which is either active or has been in remission for less than one year or treatment with antineoplastic drugs within the past 6 months 9. Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, physical examination, ECG, or diagnostic laboratory test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Clinical ResponseTimepoint: Test Of Cure visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical responseTimepoint: visit 3 and EOT;Microbiological responseTimepoint: EOT and TOC Visits;Safety evaluationTimepoint: Test of Cure visit | — |
Countries
India
Contacts
Public ContactDr Farzana Lakdavala
Wockhardt Ltd
Outcome results
None listed