Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

June 26, 2020 updated by: Wockhardt

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)

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500012
        • Osmania General Hospital
      • Vijayawada, Andhra Pradesh, India, 520008
        • Government General Hospital (Associated by Government Siddhartha Medical College)
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Sanjivani Superspeciality Hospital Pvt. Ltd.
      • Himmatnagar, Gujarat, India, 383001
        • Medistar Multispeciality Hospital Pvt.Ltd.
      • Vadodara, Gujarat, India, 390021
        • GMERS Medical College & General Hospital
      • Vadodara, Gujarat, India, 391760
        • Parul Institute of Medical Science
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital
      • Mangalore, Karnataka, India, 575003
        • Vinaya Hospital and Research Centre
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
    • Kerala
      • Kozhikode, Kerala, India, Kozhikode,
        • Government Medical College
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431002
        • Ishwar Institute of Healthcare
      • Mumbai, Maharashtra, India, 400008
        • TNMC & BYL Nair Hospital
      • Mumbai, Maharashtra, India, 400022
        • LTM Medical College and General Hospital
      • Nagpur, Maharashtra, India, 440003
        • Shree Hospital & Critical Care Centre
      • Nagpur, Maharashtra, India, 440008
        • Rahate Surgical Hospital
      • Nagpur, Maharashtra, India, 440012
        • Cresent Hospital and Heart Centre
      • Nagpur, Maharashtra, India, 440018
        • Indira Gandhi Government Medical College and Hospital
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411013
        • Noble Hospital
      • Pune, Maharashtra, India, 411001,
        • B.J. Medical College and Sassoon General Hospital
      • Pune, Maharashtra, India, 411005
        • Oyster & Pearl Hospital
      • Pune, Maharashtra, India, 411057
        • Lifepoint Hospital
      • Wardha, Maharashtra, India, 442004
        • Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College
    • Maharastra
      • Nagpur, Maharastra, India, 440003
        • Government Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Hospital
      • Jaipur, Rajasthan, India, 302012
        • Marudhar Hospital
      • Jaipur, Rajasthan, India, 302001
        • S.R. Kalla Memorial Gastro & General Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • M.V. Hospital & Research Centre
      • Lucknow, Uttar Pradesh, India, 2260055
        • Ajanta Research Centre
      • Lucknow, Uttar Pradesh, India, 226010
        • KRM Hospital and Research Centre
      • Varanasi, Uttar Pradesh, India, 221009
        • Popular Hospital
      • Varanasi, Uttar Pradesh, India, 22100
        • Om Surgical & Maternity Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. Cellulitis/erysipelas: diffuse skin infection characterized by spreading areas of redness, edema, and/or induration
    2. Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration
    3. 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:

    1. Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely)
    2. ABSSSI expected to require more than 10 days of antimicrobial therapy as per the discretion of the Investigator
    3. Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene
    4. 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:
    1. Subjects who received a single dose of a short-acting antibacterial drug within 24 hours of enrolment
    2. Subjects with evidence of clinical progression of ABSSSI while on antibacterial drug therapy after at-least 48 hours
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: levonadifloxacin
oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)
Active Comparator: linezolid
oral linezolid (600 mg BID) or IV linezolid (600 mg BID)
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 0-14 days
0-14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
0-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Rakesh Chugh, MD, Wockhardt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2017

Primary Completion (Actual)

September 25, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

January 12, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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