NCT04042077

Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site infection following a cardiothoracic/related leg or abdominal surgery.

Detailed description

This is a randomized, observer-blinded, active-controlled, parallel-group, multicenter, phase IIIb study for the treatment of incisional, superficial or deep, surgical site infection after cardiothoracic /related leg or abdominal surgery (i.e patients who are at risk of microbiologically resistant infections). IV to be switched to oral delafloxacin will be compared to treatments that represent the best available therapy (BAT) for either cardiothoracic/related leg or abdominal surgical site infection (SSI). Approximately 600 male and female eligible patients will be randomly assigned in a 1:1 ratio to receive delafloxacin or BAT. For patients who are randomised to BAT, the investigator will choose one out of two treatments available (two available for the cardiothoracic/related leg and two available for abdominal SSI) as most appropriate for patient characteristics and local epidemiological pattern. Duration of study depends on treatment duration (range: minimum 5 to maximum 14 days, as per Investigator's judgment) followed by visits up to 30 days after end of treatment. Patients will be hospitalized from Screening (within 30 days from surgery) and will remain hospitalized until considered improved or cure as per Investigator's judgment.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Delafloxacin	Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
DRUG	Vancomycin	Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
DRUG	Linezolid	Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
DRUG	Piperacillin/Tazobactam	Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
DRUG	Tigecycline	Powder for solution for infusion 50 mg, TID, for 5 to 14 days

Timeline

• Start date: 2019-09-25
• Primary completion: 2020-10-07
• Completion: 2020-10-28
• First posted: 2019-08-01
• Last updated: 2022-02-02
• Results posted: 2021-10-29

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study