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

NCT03405064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2020-06-29

No results posted yet for this study

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.

Conditions

  • Acute Bacterial Skin and Skin Structure Infections

Interventions

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)

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Rakesh Chugh, MD · Wockhardt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2018-09-25
Completion
2018-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03405064 on ClinicalTrials.gov