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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
501

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • India
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: levonadifloxacin
oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
Drug: Oral Levonadifloxacin/Linezolid Tablet
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
Drug: Intravenous Levonadifloxacin/Linezolid Infusion
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)
Drug: Oral Levonadifloxacin/Linezolid Tablet
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
Drug: Intravenous Levonadifloxacin/Linezolid Infusion
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wockhardt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W-771/2349-301

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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