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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levonadifloxacin | Experimental | oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID) |
|
| linezolid | Active Comparator | oral linezolid (600 mg BID) or IV linezolid (600 mg BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Levonadifloxacin/Linezolid Tablet | Drug | oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID) |
|
| Measure | Description | 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 | 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 | 0-14 days |
| Measure | Description | 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. | 0-14 days |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh Chugh, MD | Wockhardt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osmania General Hospital | Hyderabad | Andhra Pradesh | 500012 | India | ||
| Government General Hospital (Associated by Government Siddhartha Medical College) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32738837 | Derived | 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. |
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| Intravenous Levonadifloxacin/Linezolid Infusion | Drug | IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID) |
|
| Vijayawada |
| Andhra Pradesh |
| 520008 |
| India |
| Sanjivani Superspeciality Hospital Pvt. Ltd. | Ahmedabad | Gujarat | 380015 | India |
| Medistar Multispeciality Hospital Pvt.Ltd. | Himmatnagar | Gujarat | 383001 | India |
| GMERS Medical College & General Hospital | Vadodara | Gujarat | 390021 | India |
| Parul Institute of Medical Science | Vadodara | Gujarat | 391760 | India |
| Victoria Hospital | Bangalore | Karnataka | 560002 | India |
| Vinaya Hospital and Research Centre | Mangalore | Karnataka | 575003 | India |
| Mysore Medical College and Research Institute | Mysore | Karnataka | 570001 | India |
| Government Medical College | Kozhikode | Kerala | Kozhikode, | India |
| Ishwar Institute of Healthcare | Aurangabad | Maharashtra | 431002 | India |
| TNMC & BYL Nair Hospital | Mumbai | Maharashtra | 400008 | India |
| LTM Medical College and General Hospital | Mumbai | Maharashtra | 400022 | India |
| Government Medical College and Hospital | Nagpur | Maharashtra | 440003 | India |
| Shree Hospital & Critical Care Centre | Nagpur | Maharashtra | 440003 | India |
| Rahate Surgical Hospital | Nagpur | Maharashtra | 440008 | India |
| Cresent Hospital and Heart Centre | Nagpur | Maharashtra | 440012 | India |
| Indira Gandhi Government Medical College and Hospital | Nagpur | Maharashtra | 440018 | India |
| B.J. Medical College and Sassoon General Hospital | Pune | Maharashtra | 411001, | India |
| Deenanath Mangeshkar Hospital & Research Centre | Pune | Maharashtra | 411004 | India |
| Oyster & Pearl Hospital | Pune | Maharashtra | 411005 | India |
| Noble Hospital | Pune | Maharashtra | 411013 | India |
| Lifepoint Hospital | Pune | Maharashtra | 411057 | India |
| Datta Meghe Institute of Medical Sciences (Deemed University) Jawaharlal Nehru Medical College | Wardha | Maharashtra | 442004 | India |
| S.R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302001 | India |
| SMS Hospital | Jaipur | Rajasthan | 302004 | India |
| Marudhar Hospital | Jaipur | Rajasthan | 302012 | India |
| M.V. Hospital & Research Centre | Lucknow | Uttar Pradesh | 226003 | India |
| Ajanta Research Centre | Lucknow | Uttar Pradesh | 2260055 | India |
| KRM Hospital and Research Centre | Lucknow | Uttar Pradesh | 226010 | India |
| Popular Hospital | Varanasi | Uttar Pradesh | 221009 | India |
| Om Surgical & Maternity Home | Varanasi | Uttar Pradesh | 22100 | India |
| ID | Term |
|---|---|
| C000706771 | levonadifloxacin |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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