Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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)
1 other identifier
interventional
501
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2017
Shorter than P25 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2017
CompletedFirst Submitted
Initial submission to the registry
November 22, 2017
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2018
CompletedJune 29, 2020
June 1, 2020
1.1 years
November 22, 2017
June 26, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
0-14 days
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
0-14 days
Secondary Outcomes (1)
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.
0-14 days
Study Arms (2)
levonadifloxacin
EXPERIMENTALoral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
linezolid
ACTIVE COMPARATORoral linezolid (600 mg BID) or IV linezolid (600 mg BID)
Interventions
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wockhardtlead
Study Sites (32)
Osmania General Hospital
Hyderabad, Andhra Pradesh, 500012, India
Government General Hospital (Associated by Government Siddhartha Medical College)
Vijayawada, Andhra Pradesh, 520008, India
Sanjivani Superspeciality Hospital Pvt. Ltd.
Ahmedabad, Gujarat, 380015, India
Medistar Multispeciality Hospital Pvt.Ltd.
Himmatnagar, Gujarat, 383001, India
GMERS Medical College & General Hospital
Vadodara, Gujarat, 390021, India
Parul Institute of Medical Science
Vadodara, Gujarat, 391760, India
Victoria Hospital
Bangalore, Karnataka, 560002, India
Vinaya Hospital and Research Centre
Mangalore, Karnataka, 575003, India
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001, India
Government Medical College
Kozhikode, Kerala, Kozhikode,, India
Ishwar Institute of Healthcare
Aurangabad, Maharashtra, 431002, India
TNMC & BYL Nair Hospital
Mumbai, Maharashtra, 400008, India
LTM Medical College and General Hospital
Mumbai, Maharashtra, 400022, India
Government Medical College and Hospital
Nagpur, Maharashtra, 440003, India
Shree Hospital & Critical Care Centre
Nagpur, Maharashtra, 440003, India
Rahate Surgical Hospital
Nagpur, Maharashtra, 440008, India
Cresent Hospital and Heart Centre
Nagpur, Maharashtra, 440012, India
Indira Gandhi Government Medical College and Hospital
Nagpur, Maharashtra, 440018, India
B.J. Medical College and Sassoon General Hospital
Pune, Maharashtra, 411001,, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
Oyster & Pearl Hospital
Pune, Maharashtra, 411005, India
Noble Hospital
Pune, Maharashtra, 411013, India
Lifepoint Hospital
Pune, Maharashtra, 411057, India
Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College
Wardha, Maharashtra, 442004, India
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
SMS Hospital
Jaipur, Rajasthan, 302004, India
Marudhar Hospital
Jaipur, Rajasthan, 302012, India
M.V. Hospital & Research Centre
Lucknow, Uttar Pradesh, 226003, India
Ajanta Research Centre
Lucknow, Uttar Pradesh, 2260055, India
KRM Hospital and Research Centre
Lucknow, Uttar Pradesh, 226010, India
Popular Hospital
Varanasi, Uttar Pradesh, 221009, India
Om Surgical & Maternity Home
Varanasi, Uttar Pradesh, 22100, India
Related Publications (1)
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.
PMID: 32738837DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rakesh Chugh, MD
Wockhardt
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2017
First Posted
January 19, 2018
Study Start
August 25, 2017
Primary Completion
September 25, 2018
Study Completion
November 30, 2018
Last Updated
June 29, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share