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

Status:	Completed
Conditions:	Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:	Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	December 2005
End Date:	October 2007

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.

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.

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.

We found this trial at

sites

Clinical Trial Facility in Winston-Salem North Carolina

Winston-Salem, North Carolina

from

Winston-Salem, NC