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

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.

Timeline

Start

2017-08-25

Primary completion

2018-09-25

Completion

2018-11-30

Outcome

Met primary endpoint

paper As the lowerbound of the 95% CI around the treatment difference was greater than -15% for both subgroups PMID 32738837 ↗

paper the primary objective of the study was met. PMID 32738837 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levonadifloxacin	Small molecule	800 mg	Oral
Subject	Levonadifloxacin	Small molecule	1000 mg	Oral
Subject	Linezolid	Other / unclassified	600 mg	Oral

Indications

No indication recorded.