NCT03405064

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Bacterial Skin and Skin Structure Infections

Interventions

Type	Name	Description
DRUG	Oral Levonadifloxacin/Linezolid Tablet	oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
DRUG	Intravenous Levonadifloxacin/Linezolid Infusion	IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)

Timeline

• Start date: 2017-08-25
• Primary completion: 2018-09-25
• Completion: 2018-11-30
• First posted: 2018-01-19
• Last updated: 2020-06-29

Locations

32 sites across 1 country: India