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Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

NCT02127970 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 698

Last updated 2018-09-28

Study results available
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Summary

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

Conditions

  • Abscess
  • Wound Infection
  • Surgical Site Infection
  • Cellulitis

Interventions

DRUG

Dalbavancin

Dalbavancin IV infusion over 30 minutes.

DRUG

Dalbavancin-matching Placebo

Dalbavancin-matching placebo IV infusion over 30 minutes.

Sponsors & Collaborators

  • Durata Therapeutics Inc., an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Urania Rappo, MD · Allergan

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
2014-04-18
Primary Completion
2015-03-11
Completion
2015-03-11

Countries

  • United States
  • Bulgaria
  • Croatia
  • Estonia
  • Georgia
  • Hungary
  • Latvia
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

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 NCT02127970 on ClinicalTrials.gov