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Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

NCT01431339 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2014-02-12

Study results available
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Summary

The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.

Conditions

  • Abscess
  • Wound Infection
  • Surgical Site Infection
  • Cellulitis

Interventions

DRUG

IV Dalbavancin

IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

DRUG

Vancomycin/Linezolid

IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days

Sponsors & Collaborators

  • Durata Therapeutics Inc., an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Michael Dunne, MD · Durata Therapeutics Inc., an affiliate of Allergan plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • United States
  • Bulgaria
  • Estonia
  • Hungary
  • Israel
  • Latvia
  • Lithuania
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

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Entities

Diseases

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 NCT01431339 on ClinicalTrials.gov