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)

NCT01119105 ↗

Phase 2 Completed 210 enrolled Nabriva Therapeutics AG

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-05
Primary completion: 2010-12-31
Completion: 2011-02-03

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lefamulin	Other / unclassified	100 mg	Intravenous
Subject	Lefamulin	Other / unclassified	150 mg	Intravenous
Comparator	Vancomycin	Other / unclassified	—	Intravenous

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)

Summary

Timeline

Publications

Drugs

Indications