Back to resultsComparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Primary Purpose
Acute Bacterial Skin and Skin Structure Infections
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Oral Levonadifloxacin/Linezolid Tablet
Intravenous Levonadifloxacin/Linezolid Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bacterial Skin and Skin Structure Infections
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
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:
- 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
Sites / Locations
- Osmania General Hospital
- Government General Hospital (Associated by Government Siddhartha Medical College)
- Sanjivani Superspeciality Hospital Pvt. Ltd.
- Medistar Multispeciality Hospital Pvt.Ltd.
- GMERS Medical College & General Hospital
- Parul Institute of Medical Science
- Victoria Hospital
- Vinaya Hospital and Research Centre
- Mysore Medical College and Research Institute
- Government Medical College
- Ishwar Institute of Healthcare
- TNMC & BYL Nair Hospital
- LTM Medical College and General Hospital
- Shree Hospital & Critical Care Centre
- Rahate Surgical Hospital
- Cresent Hospital and Heart Centre
- Indira Gandhi Government Medical College and Hospital
- B.J. Medical College and Sassoon General Hospital
- Deenanath Mangeshkar Hospital & Research Centre
- Oyster & Pearl Hospital
- Noble Hospital
- Lifepoint Hospital
- Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College
- Government Medical College and Hospital
- S.R. Kalla Memorial Gastro & General Hospital
- SMS Hospital
- Marudhar Hospital
- M.V. Hospital & Research Centre
- Ajanta Research Centre
- KRM Hospital and Research Centre
- Popular Hospital
- Om Surgical & Maternity Home
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
levonadifloxacin
linezolid
Arm Description
oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
oral linezolid (600 mg BID) or IV linezolid (600 mg BID)
Outcomes
Primary Outcome Measures
The non-inferiority of oral levonadifloxacin with oral linezolid in ABSSSI by measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in oral treatment subgroups
To establish the non-inferiority of IV levonadifloxacin with IV linezolid in ABSSSI measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in IV treatment subgroups
Secondary Outcome Measures
The safety of oral and IV levonadifloxacin based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03405064
Brief Title
Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Official Title
A Phase III, Multi-centre, Randomized Study to Compare the Efficacy and Safety of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wockhardt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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. Each subgroup will comprise of two treatment arms.
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 with either oral or IV therapy based on clinical judgement i.e subjects who require IV therapy (like subjects with severe ABSSSI or where oral administration is not feasible).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin Structure Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
501 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levonadifloxacin
Arm Type
Experimental
Arm Description
oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
Arm Title
linezolid
Arm Type
Active Comparator
Arm Description
oral linezolid (600 mg BID) or IV linezolid (600 mg BID)
Intervention Type
Drug
Intervention Name(s)
Oral Levonadifloxacin/Linezolid Tablet
Intervention Description
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
Intervention Type
Drug
Intervention Name(s)
Intravenous Levonadifloxacin/Linezolid Infusion
Intervention Description
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)
Primary Outcome Measure Information:
Title
The non-inferiority of oral levonadifloxacin with oral linezolid in ABSSSI by measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in oral treatment subgroups
Time Frame
0-14 days
Title
To establish the non-inferiority of IV levonadifloxacin with IV linezolid in ABSSSI measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in IV treatment subgroups
Time Frame
0-14 days
Secondary Outcome Measure Information:
Title
The safety of oral and IV levonadifloxacin based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study.
Time Frame
0-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Chugh, MD
Organizational Affiliation
Wockhardt
Official's Role
Study Director
Facility Information:
Facility Name
Osmania General Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500012
Country
India
Facility Name
Government General Hospital (Associated by Government Siddhartha Medical College)
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520008
Country
India
Facility Name
Sanjivani Superspeciality Hospital Pvt. Ltd.
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Medistar Multispeciality Hospital Pvt.Ltd.
City
Himmatnagar
State/Province
Gujarat
ZIP/Postal Code
383001
Country
India
Facility Name
GMERS Medical College & General Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Facility Name
Parul Institute of Medical Science
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
Victoria Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Vinaya Hospital and Research Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
Mysore Medical College and Research Institute
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Government Medical College
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
Kozhikode,
Country
India
Facility Name
Ishwar Institute of Healthcare
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431002
Country
India
Facility Name
TNMC & BYL Nair Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
LTM Medical College and General Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
Shree Hospital & Critical Care Centre
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Rahate Surgical Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440008
Country
India
Facility Name
Cresent Hospital and Heart Centre
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Indira Gandhi Government Medical College and Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440018
Country
India
Facility Name
B.J. Medical College and Sassoon General Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001,
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Oyster & Pearl Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411005
Country
India
Facility Name
Noble Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Facility Name
Lifepoint Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411057
Country
India
Facility Name
Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College
City
Wardha
State/Province
Maharashtra
ZIP/Postal Code
442004
Country
India
Facility Name
Government Medical College and Hospital
City
Nagpur
State/Province
Maharastra
ZIP/Postal Code
440003
Country
India
Facility Name
S.R. Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
SMS Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Marudhar Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302012
Country
India
Facility Name
M.V. Hospital & Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Ajanta Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
2260055
Country
India
Facility Name
KRM Hospital and Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226010
Country
India
Facility Name
Popular Hospital
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221009
Country
India
Facility Name
Om Surgical & Maternity Home
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
22100
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32738837
Citation
Bhatia A, Mastim M, Shah M, Gutte R, Joshi P, Kumbhar D, Periasamy H, Palwe SR, Chavan R, Bhagwat S, Patel M, Llorens L, Friedland HD. Efficacy and Safety of a Novel Broad-Spectrum Anti-MRSA Agent Levonadifloxacin Compared with Linezolid for Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Openlabel, Randomized Study. J Assoc Physicians India. 2020 Aug;68(8):30-36.
Results Reference
derived
Learn more about this trial
Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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