A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
Phase 2
Completed
- Conditions
- Soft Tissue Infections
- Interventions
- Drug: beta-lactamDrug: Standard care
- Registration Number
- NCT00303589
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 313
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 beta-lactam - 2 beta-lactam - 3 Standard care -
- Primary Outcome Measures
Name Time Method Clinical cure rate. Event driven
- Secondary Outcome Measures
Name Time Method Adverse events; laboratory abnormalities Throughout study Bacteriological outcome Event driven Time to clinical cure Event driven Time to resolution of signs and symptoms of skin or soft tissue infection Event driven