Status:
COMPLETED
Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Lead Sponsor:
Wockhardt
Conditions:
Acute Bacterial Skin and Skin Structure Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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. ...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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:
- Cellulitis/erysipelas: diffuse skin infection characterized by spreading areas of redness, edema, and/or induration
- Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration
- 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
- 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
- 1\. 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:
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- Subjects who received a single dose of a short-acting antibacterial drug within 24 hours of enrolment
- Subjects with evidence of clinical progression of ABSSSI while on antibacterial drug therapy after at-least 48 hours
- Subjects who received an antibacterial drug for surgical prophylaxis and subsequently develop ABSSSI 3. Subjects with current history or diagnosis of HIV, positive test result for hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) 4. Subjects with any clinically significant abnormalities in pulmonary, gastrointestinal, endocrine, hepatic or renal systems
Key Trial Info
Start Date :
August 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT03405064
Start Date
August 25 2017
End Date
November 30 2018
Last Update
June 29 2020
Active Locations (32)
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1
Osmania General Hospital
Hyderabad, Andhra Pradesh, India, 500012
2
Government General Hospital (Associated by Government Siddhartha Medical College)
Vijayawada, Andhra Pradesh, India, 520008
3
Sanjivani Superspeciality Hospital Pvt. Ltd.
Ahmedabad, Gujarat, India, 380015
4
Medistar Multispeciality Hospital Pvt.Ltd.
Himmatnagar, Gujarat, India, 383001