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

Phase 3

Completed

• Conditions: Acute Bacterial Skin and Skin Structure Infections
• Interventions: Drug: Oral Levonadifloxacin/Linezolid Tablet; Drug: Intravenous Levonadifloxacin/Linezolid Infusion

• Registration Number: NCT03405064
• Lead Sponsor: Wockhardt

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).

Study Timeline

• Study Start: 2017-08-25
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2018-09-25
• Study Completion: 2018-11-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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:

  2. Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely)

  3. ABSSSI expected to require more than 10 days of antimicrobial therapy as per the discretion of the Investigator

  4. Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene

  5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
linezolid	Oral Levonadifloxacin/Linezolid Tablet	oral linezolid (600 mg BID) or IV linezolid (600 mg BID)
levonadifloxacin	Oral Levonadifloxacin/Linezolid Tablet	oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
levonadifloxacin	Intravenous Levonadifloxacin/Linezolid Infusion	oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
linezolid	Intravenous Levonadifloxacin/Linezolid Infusion	oral linezolid (600 mg BID) or IV linezolid (600 mg BID)

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (32)

Government Medical College; 🇮🇳 Kozhikode, Kerala, India

LTM Medical College and General Hospital; 🇮🇳 Mumbai, Maharashtra, India

Oyster & Pearl Hospital; 🇮🇳 Pune, Maharashtra, India

Lifepoint Hospital; 🇮🇳 Pune, Maharashtra, India

Noble Hospital; 🇮🇳 Pune, Maharashtra, India

M.V. Hospital & Research Centre; 🇮🇳 Lucknow, Uttar Pradesh, India

Government Medical College and Hospital; 🇮🇳 Nagpur, Maharastra, India

Ajanta Research Centre; 🇮🇳 Lucknow, Uttar Pradesh, India

KRM Hospital and Research Centre; 🇮🇳 Lucknow, Uttar Pradesh, India

Shree Hospital & Critical Care Centre; 🇮🇳 Nagpur, Maharashtra, India

Victoria Hospital; 🇮🇳 Bangalore, Karnataka, India

Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College; 🇮🇳 Wardha, Maharashtra, India

Sanjivani Superspeciality Hospital Pvt. Ltd.; 🇮🇳 Ahmedabad, Gujarat, India

Osmania General Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India

TNMC & BYL Nair Hospital; 🇮🇳 Mumbai, Maharashtra, India

Vinaya Hospital and Research Centre; 🇮🇳 Mangalore, Karnataka, India

Cresent Hospital and Heart Centre; 🇮🇳 Nagpur, Maharashtra, India

GMERS Medical College & General Hospital; 🇮🇳 Vadodara, Gujarat, India

Mysore Medical College and Research Institute; 🇮🇳 Mysore, Karnataka, India

Ishwar Institute of Healthcare; 🇮🇳 Aurangabad, Maharashtra, India

Government General Hospital (Associated by Government Siddhartha Medical College); 🇮🇳 Vijayawada, Andhra Pradesh, India

Om Surgical & Maternity Home; 🇮🇳 Varanasi, Uttar Pradesh, India

SMS Hospital; 🇮🇳 Jaipur, Rajasthan, India

Marudhar Hospital; 🇮🇳 Jaipur, Rajasthan, India

S.R. Kalla Memorial Gastro & General Hospital; 🇮🇳 Jaipur, Rajasthan, India

Medistar Multispeciality Hospital Pvt.Ltd.; 🇮🇳 Himmatnagar, Gujarat, India

Parul Institute of Medical Science; 🇮🇳 Vadodara, Gujarat, India

Rahate Surgical Hospital; 🇮🇳 Nagpur, Maharashtra, India

B.J. Medical College and Sassoon General Hospital; 🇮🇳 Pune, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Centre; 🇮🇳 Pune, Maharashtra, India

Indira Gandhi Government Medical College and Hospital; 🇮🇳 Nagpur, Maharashtra, India

Popular Hospital; 🇮🇳 Varanasi, Uttar Pradesh, India