Phase 2 N=210 Randomized Quadruple-blind Treatment

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)

Bacterial Infections · Infection

Bottom Line

View on ClinicalTrials.gov: NCT01119105 ↗

Enrolled (actual)

210

Serious AEs

2.4%

Results posted

Oct 2020

Primary outcome: Primary: Clinical Response — 54; 48; 47; 6 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BC-3781 (Drug); Vancomycin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nabriva Therapeutics AG
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Response	41; 42; 42; 8; 6; 6	—
PRIMARY Clinical Response	41; 42; 42; 8; 6; 6	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Uncomplicated skin and skin structure infection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01119105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.