Clinical trial NCT03405064: Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Skin and Skin Structure Infections
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2018-01-19
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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
timeFrame: 0-14 days
measure: 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
timeFrame: 0-14 days
Secondary outcomes:
measure: 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.
timeFrame: 0-14 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Government General Hospital (Associated by Government Siddhartha Medical College)
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Sanjivani Superspeciality Hospital Pvt. Ltd.
state: Gujarat
city: Himmatnagar
country: India
facility: Medistar Multispeciality Hospital Pvt.Ltd.
state: Gujarat
city: Vadodara
country: India
facility: GMERS Medical College & General Hospital
state: Gujarat
city: Vadodara
country: India
facility: Parul Institute of Medical Science
state: Gujarat
city: Bangalore
country: India
facility: Victoria Hospital
state: Karnataka
city: Mangalore
country: India
facility: Vinaya Hospital and Research Centre
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College and Research Institute
state: Karnataka
city: Kozhikode
country: India
facility: Government Medical College
state: Kerala
city: Aurangabad
country: India
facility: Ishwar Institute of Healthcare
state: Maharashtra
city: Mumbai
country: India
facility: TNMC & BYL Nair Hospital
state: Maharashtra
city: Mumbai
country: India
facility: LTM Medical College and General Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Shree Hospital & Critical Care Centre
state: Maharashtra
city: Nagpur
country: India
facility: Rahate Surgical Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Cresent Hospital and Heart Centre
state: Maharashtra
city: Nagpur
country: India
facility: Indira Gandhi Government Medical College and Hospital
state: Maharashtra
city: Pune
country: India
facility: B.J. Medical College and Sassoon General Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Oyster & Pearl Hospital
state: Maharashtra
city: Pune
country: India
facility: Noble Hospital
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Hospital
state: Maharashtra
city: Wardha
country: India
facility: Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College and Hospital
state: Maharastra
city: Jaipur
country: India
facility: S.R. Kalla Memorial Gastro & General Hospital
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Marudhar Hospital
state: Rajasthan
city: Lucknow
country: India
facility: M.V. Hospital & Research Centre
state: Uttar Pradesh
city: Lucknow
country: India
facility: Ajanta Research Centre
state: Uttar Pradesh
city: Lucknow
country: India
facility: KRM Hospital and Research Centre
state: Uttar Pradesh
city: Varanasi
country: India
facility: Popular Hospital
state: Uttar Pradesh
city: Varanasi
country: India
facility: Om Surgical & Maternity Home
state: Uttar Pradesh
Study officials:
affiliation: Wockhardt
name: Rakesh Chugh, MD
role: STUDY_DIRECTOR
References:
citation: 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.