Trial Information

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

Status: Completed

Protocol Number: WI18274

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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.

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. Target sample size is 300.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Soft Tissue Infections

Intervention Type: Drug

Intervention Name: beta-lactam

Primary Outcome: 1. Clinical cure rate. Time frame: Event driven

Key Secondary Outcomes: 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

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.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 03/10/2006

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Lima, Peru, 27
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 2:14:30 PM


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