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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00303589

Purpose

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.

Condition	Intervention	Phase
Soft Tissue Infections	Drug: beta-lactam Drug: Standard care	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Clinical cure rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to clinical cure [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Time to resolution of signs and symptoms of skin or soft tissue infection [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Bacteriological outcome [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Adverse events; laboratory abnormalities [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	313
Study Completion Date:	October 2007

Arms	Assigned Interventions
Experimental: 1	Drug: beta-lactam 750mg iv q8h
Experimental: 2	Drug: beta-lactam 1500mg iv q8h
Active Comparator: 3	Drug: Standard care As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303589

Show 61 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00303589 History of Changes
Other Study ID Numbers:	WI18274
Study First Received:	March 16, 2006
Last Updated:	May 13, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Soft Tissue Infections
Infection
Lactams
Beta-Lactams

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012