Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

NCT01984684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2017-11-17

Study results available
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Summary

The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Conditions

  • Skin and Subcutaneous Tissue Bacterial Infections
  • Skin Structures and Soft Tissue Infections

Interventions

DRUG

delafloxacin

DRUG

vancomycin

DRUG

aztreonam

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sue K Cammarata, 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
2014-05-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Mexico
  • Moldova
  • Peru
  • Romania
  • Slovakia
  • South Korea
  • Taiwan

Study Locations

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Entities

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 NCT01984684 on ClinicalTrials.gov