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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
268
Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days
Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days
Solution for infusion or tablet, 600 mg BID, for 5 to 14 days
Hospital Agostino Gemelli
Roma, Italy
Number of Participants With Clinical Success at Test Of Cure Visit
Clinical Success defined as the clinical response of "Cure" or "improved". Below the definitions: * Cure: The complete resolution of all baseline signs and symptoms of SSI * Improved: two or more signs and/or symptoms (but not all) were considered resolved thus the patient had improved to an extent that no additional antibiotic treatment was necessary.
Time frame: 7-14 days after last dose
Hospital Infection Related Length of Stay (IRLOS)
Length of Stay since beginning of therapy till patient stabilization and considered suitable for hospital discharge
Time frame: up to 14 days
Hospital Length of Stay (LOS)
Length of Stay since Screening till actual hospital discharge
Time frame: up to 45 days (Late Follow Up visit)
Number of Participants Eligible to Switch to Oral Formulation According to Blinded Observer's Assessment
Blinded assessment based on patient stabilization and ability to tolerate OS diet. In particular, the following details had to be met: Systolic blood pressure normal/not clinically significant abnormal No infection related tachycardia Afebrile status; body temperature \<38°C for at least 24 hours\* WBC count normalized/not clinically significant abnormal Patient able to tolerate PO diet/to take PO treatment and no GI absorption problem The measure counts only the participants eligible to switch, without taking into account the actually switched. Indeed, only linezolid in the BAT has an equivalent oral formulation suitable for the switch.
Time frame: up to 14 days
Microbiological Response
Documented or presumed eradication or persistence
Time frame: up to 14 days (End Of Treatment visit) and 7-14 days after last dose (Test Of Cure visit)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days
Powder for solution for infusion 50 mg, TID, for 5 to 14 days