A Phase III, Multi-centre, Randomized Study to Compare the Efficacy and Safety ofLevonadifloxacin (IV and Oral) with Linezolid (IV and Oral) in Acute Bacterial Skin andSkin Structure Infections (ABSSSI)
- Conditions
- Health Condition 1: null- Adult subjects diagnosed with Acute Bacterial Skin and Skin Structure Infections suspectedto be caused by Gram-positive bacteria, including Methicillin-resistantStaphylococcus aureus (MRSA)Health Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue
- Registration Number
- CTRI/2017/06/008843
- Lead Sponsor
- Wockhardt BioAg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Clinical ResponseTimepoint: Test Of Cure visit
- Secondary Outcome Measures
Name Time Method Clinical responseTimepoint: visit 3 and EOT;Microbiological responseTimepoint: EOT and TOC Visits;Safety evaluationTimepoint: Test of Cure visit