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NCT Number: NCT01119105

Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

This is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BC-3781 Study Center 002, Chula Vista, California, United States

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About this study

The purpose of the study is to determine the efficacy of 2 dose regimens of BC-3781 versus the licensed medicinal product vancomycin over 5 to 14 days. The population in this study will be patients with an acute bacterial skin and skin structure infection (ABSSSI) and they will receive treatment with one of two doses of BC-3781 or vancomycin, a standard treatment for this condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients > 18
  • Documented acute bacterial skin and skin structure infection

Exclusion criteria

  • Uncomplicated skin and skin structure infection

Treatment and study plan

BC-3781

Drug

BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Vancomycin

Drug

Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Primary outcomes

  1. Clinical Response

    Time frame: Test of Cure (TOC), 7 - 14 days post final treatment

    Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.

  2. Clinical Response

    Time frame: Test of Cure (TOC), 7 - 14 days post final treatment

    Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required

Sponsors and collaborators

Lead sponsor

Nabriva Therapeutics AG

Industry

Registry information

Official study title

A Phase II, Multi-center, Randomized, Double-blind Study Comparing the Safety and Efficacy of Two Doses of BC-3781 Versus Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 7, 2010
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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