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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00303589
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Soft Tissue Infections Drug: Standard care Drug: beta-lactam Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2005
Primary Completion Date : October 2007
Study Completion Date : October 2007
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: beta-lactam
750mg iv q8h
Experimental: 2 Drug: beta-lactam
1500mg iv q8h
Active Comparator: 3 Drug: Standard care
As prescribed

Outcome Measures

Primary Outcome Measures :
  1. Clinical cure rate. [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Time to clinical cure [ Time Frame: Event driven ]
  2. Time to resolution of signs and symptoms of skin or soft tissue infection [ Time Frame: Event driven ]
  3. Bacteriological outcome [ Time Frame: Event driven ]
  4. Adverse events; laboratory abnormalities [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303589

  Show 62 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00303589     History of Changes
Other Study ID Numbers: WI18274
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Communicable Diseases
Soft Tissue Infections
Anti-Bacterial Agents
Anti-Infective Agents