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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)

NCT ID: NCT01119105

Last Updated: 2020-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bacterial Infections Infection

Keywords

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acute bacterial skin and skin structure infection bacteria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BC-3781 dose 100mg

Group Type EXPERIMENTAL

BC-3781

Intervention Type DRUG

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

BC-3781 dose 150mg

Group Type EXPERIMENTAL

BC-3781

Intervention Type DRUG

BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

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

Interventions

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BC-3781

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

Intervention Type DRUG

BC-3781

BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Intervention Type DRUG

Vancomycin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Uncomplicated skin and skin structure infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nabriva Therapeutics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William T. Prince, Dr.

Role: STUDY_CHAIR

Nabriva Therapeutics AG

Locations

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BC-3781 Study Center 002

Chula Vista, California, United States

Site Status

BC-3781 Study Center 001

La Mesa, California, United States

Site Status

BC-3781 Study Center 003

Oceanside, California, United States

Site Status

BC-3781 Study Center 012

Columbus, Georgia, United States

Site Status

BC-3781 Study Center 018

Savannah, Georgia, United States

Site Status

BC-3781 Study Center 021

Baton Rouge, Louisiana, United States

Site Status

BC-3781 Study Center 023

Lafayette, Louisiana, United States

Site Status

BC-3781 Study Center 004

Butte, Montana, United States

Site Status

BC-3781 Study Center 016

Somers Point, New Jersey, United States

Site Status

Countries

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United States

References

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Rubino CM, Xue B, Bhavnani SM, Prince WT, Ivezic-Schoenfeld Z, Wicha WW, Ambrose PG. Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Jan;59(1):282-8. doi: 10.1128/AAC.02033-13. Epub 2014 Oct 27.

Reference Type DERIVED
PMID: 25348519 (View on PubMed)

Other Identifiers

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NAB-BC-3781-2001

Identifier Type: -

Identifier Source: org_study_id