Acute Bacterial Skin and Skin Structure Infection MedDRA version: 20.1 Level: PT Classification code 10052891 Term: Skin bacterial infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: BAXDELA
Product Name: Delafloxacin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DELAFLOXACIN
CAS Number: 352458-37-8
Other descriptive name: DELAFLOXACIN
Conc
Sponsors
MENARINI RICERCHE S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Or - Deep Incisional Surgical Site Infection, involving deep soft tissues (e.g. fascia and muscle layers) at the incision site and at least one of the following findings: · purulent drainage from the deep incision but not from the organ / space component of the surgical site; · a deep incision spontaneously dehisces or is deliberately opened by a surgeon when the patient has at least one of the following signs or symptoms of infection: * fever (> 38 °C), * localized pain or tenderness; · an abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination; · diagnosis of deep incisional SSI made by the Investigator. 3. The severity of infection requires an IV treatment and patient hospitalization according to the Investigator’s judgment. 4. Females participating in the study must be either: · Females of non-childbearing potential, defined as any woman who underwent surgical sterilization or is more than 2 years post-menopausal; · Females of childbearing potential provided that they have a negative pregnancy test at Screening and are routinely using an effective method of birth control resulting in a low failure rate (i.e. hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, male partner sterilization – vasectomy– or total sexual abstinence) and continue up 30 days after last dose of study treatment. 5. Males participating in the study must agree either to abstain from sexual intercourse or to use an effective method of contraception as sterilization – vasectomy – or condom in combination with a spermicidal cream up 30 days after last dose of study treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 480 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the comparability of delafloxacin and BAT in terms of Clinical Success in patients with superficial or deep incisional SSI following a cardiothoracic / related leg or abdominal surgical procedure.;Secondary Objective: To assess the comparability of delafloxacin and BAT in patients with cardiothoracic / related leg or abdominal SSI, in terms of: - Effectiveness, microbiological response and sustained efficacy - safety and tolerability - healthcare resources consumption;Primary end point(s): Clinical Success defined as the clinical response of “Cure” or “Improved” at TOC (7 - 14 days after last dose) in the Intent-to-Treat (ITT) and the Clinical Evaluable (CE) populations.;Timepoint(s) of evaluation of this end point: TOC (7 - 14 days after last dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Hospital IRLOS (Infection Related Length of Stay) in the ITT and CE populations, beginning with first dose of study treatment and ending when the patient is considered eligible to discharge up to maximum end of treatment according to the blinded observer’s assessment - Hospital LOS (Length of Stay) in the ITT and CE populations, beginning with the diagnosis of the SSI (Screening) and ending with actual discharge - Microbiological response at EOT and at TOC Visits in the Microbiologically Intent-to- Treat (MITT) and in the Microbiologically Evaluable (ME) populations - Incidence, intensity (severity), seriousness and treatment-causality of Treatment-Emergent AEs (TEAEs, i.e. AEs that occurred after the first study drug intake).;Timepoint(s) of evaluation of this end point: Clinical response will be based on the Investigator’s assessment of the patient’s signs and symptoms of infection at the EOT, TOC and LFU Visits Microbiological response will be generated at EOT and TOC assessments at both pathogen and patient levels on the basis of the results of the infection site specimen(s) and blood cultures at baseline and follow-up and susceptibility testing, performed at the microbiological Centralized laboratory | — |
Countries
Austria, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Italy, Latvia, Poland, Romania, Serbia, Slovenia, Spain, United Kingdom
Contacts
Public ContactCorp. Director Of Clinical Sciences
MENARINI RICERCHE S.p.A.
Outcome results
None listed