NCT01119105

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2011

Completed
9.7 years until next milestone

Results Posted

Study results publicly available

October 27, 2020

Completed
Last Updated

November 17, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

May 5, 2010

Results QC Date

October 5, 2020

Last Update Submit

October 29, 2020

Conditions

Bacterial InfectionsInfection

Keywords

acute bacterial skin and skin structure infectionbacteria

Outcome Measures

Primary Outcomes (2)

  • Clinical Response

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

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

  • Clinical Response

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

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

Study Arms (3)

BC-3781 dose 100mg

EXPERIMENTAL
Drug: BC-3781

BC-3781 dose 150mg

EXPERIMENTAL
Drug: BC-3781

Vancomycin

ACTIVE COMPARATOR
Drug: Vancomycin

Interventions

BC-3781DRUG

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 100mg
VancomycinDRUG

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

Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Uncomplicated skin and skin structure infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

BC-3781 Study Center 002

Chula Vista, California, 91911, United States

Location

BC-3781 Study Center 001

La Mesa, California, 91942, United States

Location

BC-3781 Study Center 003

Oceanside, California, 92056, United States

Location

BC-3781 Study Center 012

Columbus, Georgia, 31904, United States

Location

BC-3781 Study Center 018

Savannah, Georgia, 31406, United States

Location

BC-3781 Study Center 021

Baton Rouge, Louisiana, 70808, United States

Location

BC-3781 Study Center 023

Lafayette, Louisiana, 70503, United States

Location

BC-3781 Study Center 004

Butte, Montana, 59701, United States

Location

BC-3781 Study Center 016

Somers Point, New Jersey, 08244, United States

Location

Related Publications (1)

  • 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.

    PMID: 25348519DERIVED

MeSH Terms

Conditions

Bacterial InfectionsInfections

Interventions

lefamulinVancomycin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Jennifer Schranz, M.D., Chief Medical Officer
Organization
Nabriva Therapeutics
jennifer.schranz@nabriva.com
610-981-2842

Study Officials

  • William T. Prince, Dr.

    Nabriva Therapeutics AG

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 7, 2010

Study Start

May 1, 2010

Primary Completion

December 31, 2010

Study Completion

February 3, 2011

Last Updated

November 17, 2020

Results First Posted

October 27, 2020

Record last verified: 2020-10

Locations

US(9)