NCT00303589

A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

A Phase II Prospective, Open Label, Randomized, Active-controlled, Parallel Group, Multi-center 'Proof of Concept' Trial in Adult Patients With Complicated Skin or Skin Structure Infections Requiring Hospitalization.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	Standard care	As prescribed
DRUG	beta-lactam	750mg iv q8h
DRUG	beta-lactam	1500mg iv q8h

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-03-17
• Last updated: 2016-11-02

Locations

62 sites across 11 countries: United States, Argentina, Bulgaria, Estonia, Germany, Hungary, Latvia, Lithuania, Peru, Romania, South Africa