A randomized, observer-blinded, active-controlled, Phase IIIb study to compare IV / Oral delafloxacin fixed-dose monotherapy with best available treatments in a microbiologically enriched population with surgical site infections - DRESS - DELAFLOXACIN INTRAVENOUS AND ORAL MONOTHERAPY

MENARINI RICERCHE S.p.A.0 sites600 target enrollmentJune 6, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 6, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

MENARINI RICERCHE S.p.A.

•1\. Male or female patients aged more than 18 years.
•2\. Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of SSI according to the CDC definition1, namely:
•\- Superficial Incisional Surgical Site Infection, involving only skin and subcutaneous tissue of the incision, and at least one of the following local findings:
•· purulent drainage from the superficial incision;
•· organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision;
•· superficial incision is deliberately explored by surgeon AND the patient has at least one of the following signs or symptoms of infection:
•\* pain or tenderness,
•\* localized swelling,
•\* redness or heat;
•· diagnosis of superficial incisional SSI made by the Investigator.

•1\. Previous IV antimicrobial therapy exceeding 24 hour duration administered during 72 hours prior to the first dose of study treatment.
•2\. Any infection expected to require systemic antimicrobial agents other than study treatment(s)
•5\. Medical history of myasthenia gravis.
•6\. Medical history of C. difficile diarrhea.
•8\. Organ\-space infection.
•13\. Use of systemic corticosteroids for more than 10 days at a dose equivalent to more than 15 mg prednisolone in the previous 2 weeks.
•14\. Patients with end\-stage renal disease on hemodialysis or peritoneal dialysis or creatinine clearance (CrCl) \< 15 mL/min using the Cockcroft\-Gault formula.