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

• Status: Terminated
• Trial end date: 2020-10-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: Delafloxacin; Fluoroquinolones; Linezolid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam; Tigecycline; Vancomycin

Criteria

Inclusion Criteria:

• Male or female patients aged more than 18 years.

• 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 superficial or deep SSI according to the CDC definition.

• The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.

Exclusion Criteria:

• Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.

• Any infection expected to require systemic antimicrobial agents other than study treatment(s).

• Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs

• Medical history of central nervous system (CNS) disorders

• Medical history of myasthenia gravis.

• Medical history of C. difficile diarrhea.

• Organ-space infection.

• Complicated Intra-Abdominal Infection (cIAI)

• Chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with SSI healing.

• Underlying disease leading to deep immunosuppressive status.

• End-stage renal disease, CrCl <15 mL/min.