drugset / Trial / NCT00303589
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-12
- Primary completion
- 2007-10
- Completion
- 2007-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aztreonam | Small molecule | — | — |
| Comparator | Ciprofloxacin | Small molecule | — | — |
| Comparator | FLOXACILLIN | Small molecule | — | — |
| Comparator | Vancomycin | Other / unclassified | — | — |
| Comparator | nafcillin | Small molecule | — | — |
Indications
No indication recorded.