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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00303589
First received: March 16, 2006
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This 3 arm study will compare the efficacy and safety of beta-lactam with that o f 'standard care' in patients with complicated skin and skin structure infection s requiring hospitalization. Patients will be randomized to receive 1)beta-lacta m 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipa ted time on study treatment is <3 months and the target sample size is 100-500 i ndividuals.


Condition Intervention Phase
Soft Tissue Infections
Drug: Standard care
Drug: beta-lactam
Phase 2

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 Start Date: December 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00303589

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00303589     History of Changes
Other Study ID Numbers: WI18274
Study First Received: March 16, 2006
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Infection
Soft Tissue Infections
Beta-Lactams
Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014