Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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 Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
- Buenos Aires
- Córdoba
- Granadero Baigorria
- Neuquen
- Palomar
- Parana
- Rosario
- Santa Fe
Bulgaria
- Pleven
- Plovdiv
- Sofia
- Varna
Estonia
Germany
Hungary
Latvia
Lithuania
Peru
Romania
- Bucharest
- Cluj-Napoca
- Constanta
- Tirgu-Mures
South Africa
- Benoni
- Cape Town
- Port Elizabeth
- Pretoria
- Sommerset West
- Temba
United States
- Detroit, MI
- Minneapolis, MN
- Winston-Salem, NC
