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Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

NCT00719810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-07-14

Study results available
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Summary

The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.

Conditions

  • Skin Structure Infections
  • Bacterial Skin Diseases
  • Staphylococcal Skin Infections

Interventions

DRUG

delafloxacin

300 mg intravenous every 12 hours

DRUG

delafloxacin

450 mg intravenous every 12 hours

DRUG

tigecycline

100 mg then 50 mg intravenous tigecycline every 12 hours

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeanne Breen, MD · Melinta Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Puerto Rico

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 NCT00719810 on ClinicalTrials.gov