DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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)

Information source: Nabriva Therapeutics AG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections; Infection

Intervention: BC-3781 (Drug); BC-3781 (Drug); Vancomycin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Nabriva Therapeutics AG

Official(s) and/or principal investigator(s):
William T. Prince, Dr., Study Chair, Affiliation: Nabriva Therapeutics AG

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To assess the clinical response of 2 dose regimens of BC-3781 versus vancomycin over 5 to 14 days when administered as an intravenous infusion twice daily in clinically evaluable patients and modified intent-to-treat population

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patients > 18

- Documented acute bacterial skin and skin structure infection

Exclusion Criteria:

- Uncomplicated skin and skin structure infection

Locations and Contacts

BC-3781 Study Center 002, Chula Vista, California 91911, United States

BC-3781 Study Center 001, La Mesa, California 91942, United States

BC-3781 Study Center 003, Oceanside, California 92056, United States

BC-3781 Study Center 012, Columbus, Georgia 31904, United States

BC-3781 Study Center 018, Savannah, Georgia 31406, United States

BC-3781 Study Center 021, Baton Rouge, Louisiana 70808, United States

BC-3781 Study Center 023, Lafayette, Louisiana 70503, United States

BC-3781 Study Center 004, Butte, Montana 59701, United States

BC-3781 Study Center 016, Somers Point, New Jersey 08244, United States

Additional Information

Starting date: May 2010
Last updated: July 2, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017