Soft Tissue Infections
Conditions
Brief summary
This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' \[PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin\]. The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.
Interventions
DRUGStandard care
As prescribed
DRUGbeta-lactam
750mg iv q8h
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * skin or skin structure infection requiring hospitalization; * clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment; * material from site of infection is clinically purulent or seropurulent.
Exclusion criteria
* presenting with sustained shock (SBP\<90mm Hg for \> 2 hours, despite adequate fluid resuscitation); * known or suspected concomitant bacterial infection requiring antibiotic treatment; * skin infection or chronic non-healing ulcer of \> 2 weeks duration; * patients in whom surgery is the primary treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate. | Event driven |
Secondary
| Measure | Time frame |
|---|---|
| Time to clinical cure | Event driven |
| Time to resolution of signs and symptoms of skin or soft tissue infection | Event driven |
| Bacteriological outcome | Event driven |
| Adverse events; laboratory abnormalities | Throughout study |
Countries
Argentina, Bulgaria, Estonia, Germany, Hungary, Latvia, Lithuania, Peru, Romania, South Africa, United States
Outcome results
None listed