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

NCT ID: NCT03405064

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-25
• Study Completion Date: 2018-11-30

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).

Conditions

Acute Bacterial Skin and Skin Structure Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

levonadifloxacin

oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)

Group Type: EXPERIMENTAL

Oral Levonadifloxacin/Linezolid Tablet

Intervention Type: DRUG

oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)

Intravenous Levonadifloxacin/Linezolid Infusion

Intervention Type: DRUG

IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

linezolid

oral linezolid (600 mg BID) or IV linezolid (600 mg BID)

Group Type: ACTIVE_COMPARATOR

Oral Levonadifloxacin/Linezolid Tablet

Intervention Type: DRUG

oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)

Intravenous Levonadifloxacin/Linezolid Infusion

Intervention Type: DRUG

IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

Interventions

Oral Levonadifloxacin/Linezolid Tablet

oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)

Intervention Type: DRUG

Intravenous Levonadifloxacin/Linezolid Infusion

IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

Intervention Type: DRUG

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:

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:

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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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rakesh Chugh, MD

Role: STUDY_DIRECTOR

Wockhardt

Locations

Osmania General Hospital

Hyderabad, Andhra Pradesh, India

Government General Hospital (Associated by Government Siddhartha Medical College)

Vijayawada, Andhra Pradesh, India

Sanjivani Superspeciality Hospital Pvt. Ltd.

Ahmedabad, Gujarat, India

Medistar Multispeciality Hospital Pvt.Ltd.

Himmatnagar, Gujarat, India

GMERS Medical College & General Hospital

Vadodara, Gujarat, India

Parul Institute of Medical Science

Vadodara, Gujarat, India

Victoria Hospital

Bangalore, Karnataka, India

Vinaya Hospital and Research Centre

Mangalore, Karnataka, India

Mysore Medical College and Research Institute

Mysore, Karnataka, India

Government Medical College

Kozhikode, Kerala, India

Ishwar Institute of Healthcare

Aurangabad, Maharashtra, India

TNMC & BYL Nair Hospital

Mumbai, Maharashtra, India

LTM Medical College and General Hospital

Mumbai, Maharashtra, India

Government Medical College and Hospital

Nagpur, Maharashtra, India

Shree Hospital & Critical Care Centre

Nagpur, Maharashtra, India

Rahate Surgical Hospital

Nagpur, Maharashtra, India

Cresent Hospital and Heart Centre

Nagpur, Maharashtra, India

Indira Gandhi Government Medical College and Hospital

Nagpur, Maharashtra, India

B.J. Medical College and Sassoon General Hospital

Pune, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India

Oyster & Pearl Hospital

Pune, Maharashtra, India

Noble Hospital

Pune, Maharashtra, India

Lifepoint Hospital

Pune, Maharashtra, India

Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College

Wardha, Maharashtra, India

S.R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

SMS Hospital

Jaipur, Rajasthan, India

Marudhar Hospital

Jaipur, Rajasthan, India

M.V. Hospital & Research Centre

Lucknow, Uttar Pradesh, India

Ajanta Research Centre

Lucknow, Uttar Pradesh, India

KRM Hospital and Research Centre

Lucknow, Uttar Pradesh, India

Popular Hospital

Varanasi, Uttar Pradesh, India

Om Surgical & Maternity Home

Varanasi, Uttar Pradesh, India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 32738837 (View on PubMed)

Other Identifiers

W-771/2349-301

Identifier Type: -

Identifier Source: org_study_id