NCT02426918

Study of Debio 1450 for Bacterial Skin Infections

A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Debio 1450 IV	Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
DRUG	Debio 1450 Oral	Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
DRUG	Linezolid	Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
DRUG	Debio 1450 Oral Placebo	Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
DRUG	Linezolid Placebo	Linezolid placebo will be supplied as film-coated compressed tablets.
DRUG	Vancomycin IV	Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2015-04-27
• Last updated: 2019-11-13
• Results posted: 2019-11-13

Locations

22 sites across 1 country: United States