Complicated skin and skin structure infections MedDRA version: LLT Level: code Classification code 10024768
Conditions
Interventions
Product Name: Ceftobiprole
Product Code: BAL5788
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Ceftobiprole medocaril
CAS Number: 252188-71-9
Other descriptive name: (6R,
Sponsors
Basilea Pharmaceutica Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written informed consent provided. 2)Male or female patients aged = 18 years. 3)Patients who, in the opinion of the investigator, require antibiotic therapy with anti-MRSA antibiotic activity. 4)Diagnosis of an infection consistent with cSSSI (defined as infections either involving deeper soft tissue or requiring significant surgical intervention) and one or more of the following: a)Infection site within 30 days of surgery/trauma (including partial thickness burns 38°C rectal or > 37.5°C oral or > 38.5°C tympanic in the absence of anti-pyretics), o localized swelling, o localized erythema extending =10mm beyond wound edge, o localized pain, o tenderness to palpation b)Onset of an abscess (without open wound) in the 7 days before enrollment with purulent drainage or purulent aspirate and evidence of loculated fluid that requires intervention within 48 hours of enrollment, and with erythema and/or induration of =20 mm diameter, or tenderness. c)Onset of cellulitis in the 7 days before enrollment with advancing edema, erythema, or induration and one of the following: o fever (> 38°C rectal or > 37.5°C oral or > 38.5°C tympanic in the absence of anti-pyretics) or reported fever in the 3 days before enrollment. o white blood cell (WBC) count =10 x 109/L, or =10% bands, or association with lymphangitis and adenopathy. 5)Suspected or proven infection with Gram-positive pathogen(s) with biological fluid/tissue samples available from infected lesion at baseline for microbiological culture. 6)Complications of infection comprising either a requirement for surgical intervention within 48 hours of enrollment, or involvement of subcutaneous tissues. 7)Severity of infection requiring hospitalization or prolongation of hospitalization. 8)Anticipated survival > 1 month. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General: 1) Female patient who are pregnant or lactating. 2) Women of childbearing potential unable or unwilling to use an effective method of birth control. 3) Known or suspected hypersensitivity to any study medication (including ß-lactam antibiotics such as penicillins or cephalosporins or vancomycin) 4) Any known or suspected condition or concurrent treatment contraindicated by the prescribing information for vancomycin. 5) Known or suspected severe renal impairment (calculated CrCl 24 hours in the 7 days before enrollment. Systemic antimicrobial therapy for > 24 hours is permitted in case: a) The infection is caused by microbiologically-confirmed pathogens that are resistant to the previous antimicrobial agents b) The patient is clinically worsening despite at least 72 hours of treatment 15) Presence prior to study start of a pathogen known (or expected) to be resistant to either study drug 16) Suspected mixed infections that require treatment with medication other than the approved study medication 17) Self-limited infections such as isolated folliculitis or furuncules, furunculosis or carbunculosis not associated with cellulitis, or other infection that have a high cure rate after surgery alone. 18) Infections presumed at enrollment to be caused by Gram-negative pathogen(s) or mixed anaerobic/aerobic infections, such as: a) decubitus ulcers, episiotomy infection, peri-anal cellulitis, Fournier’s gangrene b) diabetic foot infections c) infections due to animal or human bites d) wound infections after surgical procedures where there is a high probability of Gram-negative pathogen(s), e.g,, if the infection extends to the oropharyngeal, gastrointestinal, urogenital or gynecological tract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical outcome following treatment with ceftobiprole or vancomycin of patients with cSSSI due to suspected or proven MRSS infection.;Secondary Objective: -To compare the microbiological outcome following treatment with ceftobiprole or vancomycinof patients with cSSSI due to suspected or proven MRSS infection. -To compare the evaluation of signs and symptoms of cSSSI infections following treatment with ceftobiprole or vancomycin. -To characterize the safety and tolerability of treatment with ceftobiprole.;Primary end point(s): | — |
Countries
Hungary, Italy, Latvia, Lithuania
Outcome results
None listed