Status:
TERMINATED
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
Lead Sponsor:
Menarini Group
Conditions:
Surgical Site Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 d...
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 cardiothora...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2020
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04042077
Start Date
September 25 2019
End Date
October 28 2020
Last Update
February 2 2022
Active Locations (1)
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1
Hospital Agostino Gemelli
Roma, Italy