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 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 Adverse events; laboratory abnormalities Throughout study