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NCT01339091 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Surgical Site Infection and Abscess, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.

Completed
Registry status
Phase 3
Development phase
573
Enrollment target
20
Study locations

NCT01339091 is a Phase 3 study of Surgical Site Infection and Abscess that has completed, run by Durata Therapeutics Inc., an affiliate of Allergan. The registered enrollment target is 573 participants, roughly in line with the 546-participant average among 25 other Surgical Site Infection trials with a reported enrollment target. The trial reports 20 study locations across 1 state.

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The verdict

NCT01339091, a Phase 3 study of Surgical Site Infection and Abscess, has completed, sponsored by Durata Therapeutics Inc., an affiliate of Allergan.

COMPLETED
Registry status
Phase 3
Development phase
573 participants
Enrollment target
20
Study locations

Study 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 proven gram-positive bacterial skin or skin structure infection.

Conditions Studied

Surgical Site Infection Abscess Cellulitis Wound Infection

Interventions

  • DRUG Dalbavancin
  • DRUG Vancomycin / Linezolid

Study Locations (20)

California

  • Durata Study Site - Anaheim
  • Durata Study Site - Azusa
  • Durata Study Site - Bellflower
  • Durata Study Site - Buena Park
  • Durata Study Site - Carmel
  • Durata Study Site - Chula Vista
  • Durata Study Site - Covina
  • Durata Study Site - Fountain Valley
  • Durata Study Site - La Mesa
  • Durata Study Site - Long Beach
  • Durata Study Site - Los Alamitos
  • Durata Study Site - Los Angeles
  • Durata Study Site - Oceanside
  • Durata Study Site - Palm Desert
  • Durata Study Site - Pasadena
  • Durata Study Site - Sacramento
  • Durata Study Site - San Diego
  • Durata Study Site - Santa Ana
  • Durata Study Site - Sylmar
  • Durata Study Site - Torrance

Trial Details

FieldValue
Enrollment Target 573 participants
Start Date 2011-03
Est. Completion 2012-11
Phase Phase 3

Sponsor

Durata Therapeutics Inc., an affiliate of Allergan

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01339091

The ClinicalTrials.gov registry entry for NCT01339091 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 573 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 546-participant average among 25 other Surgical Site Infection trials with a reported enrollment target. The listed sponsor is Durata Therapeutics Inc., an affiliate of Allergan, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Dalbavancin is the first listed.

NCT01339091 reports 20 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01339091 about?

NCT01339091 is a clinical study titled "Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections". 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 proven gram-positive bacterial skin or skin structure infect...

What is the current status of trial NCT01339091?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 573 participants. The study started on 2011-03. Estimated completion is 2012-11.

What conditions does trial NCT01339091 study?

This clinical trial studies the following conditions: Surgical Site Infection, Abscess, Cellulitis, Wound Infection.

What interventions are being tested in trial NCT01339091?

The interventions under investigation include: Dalbavancin (DRUG), Vancomycin / Linezolid (DRUG).

Who is sponsoring clinical trial NCT01339091?

This trial is sponsored by Durata Therapeutics Inc., an affiliate of Allergan, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01339091 being conducted?

This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.