CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 210 enrolled
Drug / intervention
BC-3781 +2 moredrug
Likely dose
BC-3781 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01119105
NCT01119105Phase 2Completed

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

Nabriva Therapeutics AG·interventional·Posted May 7, 2010·Updated Nov 17, 2020

In Brief

A Phase 2 clinical trial evaluating BC-3781 and Vancomycin for Bacterial Infections and Infection. Completed, enrolled 210 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2010
Enrollment StartMay 1, 2010
Primary CompletionDec 31, 2010
Study CompletionFeb 3, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.2 years ago

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-3781drug

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

Vancomycindrug

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