Complicated Skin and Soft Tissue Infections (cSSTI) MedDRA version: 8.1 Level: HLT Classification code 10040786 Term: Skin structures and soft tissue infections
Conditions
Interventions
Trade Name: Cubicin, 350 mg powder for concentrate for solution for infusion
Product Name: Daptomycin
Product Code: CB-109187
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with a diagnosis of cSSTI defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalisation and i.v. antimicrobial treatment. 2. Infection known or suspected (based on Gram's stain) to be due, at least partially, to Gram-positive bacteria. 3. Hospitalised subjects with clinical evidence of at least one of the following: - Infected ulcers includig diabetic foot ulcers not associated with osteomyelitis - Major abscess - Deep or extensive cellulitis - Post-surgical/post traumatic wound infection 4. Presence of at least two of the following signs and symptoms: - Drainage and/or discharge from the infection site - Erythema - Edema and/or induration - Heat and/or localised warmth - Pain and/or tenderness to palpation - Fluctuance 5. Presence of at least one of the following - Temperature >38.0 degrees C rectal or >37.5 degrees oral/tympanic - WBC >12 x 1000/L or with >10% bands 6. Written informed consent to participate in the study. 7. Males and females at least 18 years of age. 8. Women of childbearing potential must have a negative serum or urine pregnancy test at Baseline and must agree to an effective method of contraception throughout the study period. 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: 1. cSSTIs of the following categories: - Infected burns - Severely impaired arterial blood supply such that the likelihood of amputation of the infected anatomical site is likely - Decubitus ulcers - Infected diabetic foot ulcers associated with osteomyelitis - Infected human or animal bites - Superficial infections or abscesses in an anatomic site, such as the rectal area, where the risk of anaerobic or Gram-negative pathogen involvement is high (e.g. perirectal abscess) - Necrotising fasciitis or gangrene - cSSTI expected to require more than 14 days of intravenous antimicrobial therapy - Skin and/or skin structure infection that can be treated by surgery alone - Infections associated with a permanent prosthetic device that will not be removed within 2 days of study randomisation 2. Uncomplicated skin or soft tissue infection (e.g., simple abscesses, folliculitis, impetiginous lesions, furunculosis, superficial cellulitis). 3. Subjects with documented bacteraemia at Baseline. 4. Shock or hypotension (supine systolic blood pressure 10 mg per day prednisolone or equivalent or receiving immunosuppressant drugs after organ transplant. 11. Subjects who have received more than 48 hours of any systemic antibiotic or topical antibiotic at the infection site against Gram-positive pathogens within 48 hours of enrolment, unless these is clinical evidence of treatment failure OR documented resistance in the identified Gram-positive pathogen to the previous antibiotic therapy. 12. Complicated SSTI that is known or suspected to be a fungal, parasitic or viral infection. 13. Subjects diagnosed with pneumonia. 14. Pregnant or lactating women. 15. Severe renal impairment with creatinine clearance (CrCl) 3 times the upper limit of normal and/or bilirubin >1.5 times the upper limit of normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the clinical efficacy of daptomycin to that of the comparator arm (vancomycin or teicoplanin) in the treatment of cSSTI as measured by the proportion of subjects achieving clinical success at the Test-of-Cure (TOC) visit (Day +7 to Day+14);Secondary Objective: To compare the time to resolution of clinical signs and symptoms of cSSTI in the daptomycin arm with that of the comparator arm, according to a SSTI signs & symptoms scoring system. To compare the time to resolution of fever in daptomycin-treated subjects with that in comparator-treated subjects. To compare the microbiological efficacy of daptomycin with that of vancomycin or teicoplanin in the treatment of cSSTI as measured by the proportion of subjects achieving bacteriological eradication of Gram-positive baseline pathogens at the TOC visit. To assess and compare the resource utilisation, treatment cost, and cost-effectiveness of daptomycin with the comparator treatment over the treatment and follow-up period. To compare the duration of treatment with daptomycin with that of comparator. To compare safety of treatment with daptomycin with that of comparator.;Primary end point(s): The primary efficacy variable related to the primary objective of the study is the Clinical Success (i.e. clinical cure or clinical improvement) at the Test-of-Cure (TOC) visit in the Clinically Evaluable (CE) study population. At the time of the TOC assessment, clinical response will be determined in the CE population by comparing the subject's signs and symptoms to those recorded at the Study Baseline and classified into the following categories as described in the protocol: - Success - Failure - Unable to evaluate | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed