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

Acute Bacterial Skin and Skin Structure Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405064
• Other study ID #: W-771/2349-301
• Status: Completed
• Phase: Phase 3
• Start date: August 25, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2020
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: November 30, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infections
• Communicable Diseases
• Infection
• Skin Diseases, Bacterial

Intervention

Drug:
• Oral Levonadifloxacin/Linezolid Tablet
oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
• Intravenous Levonadifloxacin/Linezolid Infusion
IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

Locations

Country	Name	City	State
India	Sanjivani Superspeciality Hospital Pvt. Ltd.	Ahmedabad	Gujarat
India	Ishwar Institute of Healthcare	Aurangabad	Maharashtra
India	Victoria Hospital	Bangalore	Karnataka
India	Medistar Multispeciality Hospital Pvt.Ltd.	Himmatnagar	Gujarat
India	Osmania General Hospital	Hyderabad	Andhra Pradesh
India	Marudhar Hospital	Jaipur	Rajasthan
India	S.R. Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	SMS Hospital	Jaipur	Rajasthan
India	Government Medical College	Kozhikode	Kerala
India	Ajanta Research Centre	Lucknow	Uttar Pradesh
India	KRM Hospital and Research Centre	Lucknow	Uttar Pradesh
India	M.V. Hospital & Research Centre	Lucknow	Uttar Pradesh
India	Vinaya Hospital and Research Centre	Mangalore	Karnataka
India	LTM Medical College and General Hospital	Mumbai	Maharashtra
India	TNMC & BYL Nair Hospital	Mumbai	Maharashtra
India	Mysore Medical College and Research Institute	Mysore	Karnataka
India	Cresent Hospital and Heart Centre	Nagpur	Maharashtra
India	Government Medical College and Hospital	Nagpur	Maharastra
India	Indira Gandhi Government Medical College and Hospital	Nagpur	Maharashtra
India	Rahate Surgical Hospital	Nagpur	Maharashtra
India	Shree Hospital & Critical Care Centre	Nagpur	Maharashtra
India	B.J. Medical College and Sassoon General Hospital	Pune	Maharashtra
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Lifepoint Hospital	Pune	Maharashtra
India	Noble Hospital	Pune	Maharashtra
India	Oyster & Pearl Hospital	Pune	Maharashtra
India	GMERS Medical College & General Hospital	Vadodara	Gujarat
India	Parul Institute of Medical Science	Vadodara	Gujarat
India	Om Surgical & Maternity Home	Varanasi	Uttar Pradesh
India	Popular Hospital	Varanasi	Uttar Pradesh
India	Government General Hospital (Associated by Government Siddhartha Medical College)	Vijayawada	Andhra Pradesh
India	Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College	Wardha	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Wockhardt

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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