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

Phase 3 Completed 501 enrolled Wockhardt

RandomizedParallel-groupOpen-labelTreatment

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

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.