Status:
COMPLETED
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Soft Tissue Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00303589
Start Date
December 1 2005
End Date
October 1 2007
Last Update
November 2 2016
Active Locations (62)
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1
Birmingham, Alabama, United States, 35209
2
Mobile, Alabama, United States, 36608
3
Melbourne, Florida, United States, 32901
4
Miami Beach, Florida, United States, 33139