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

Condition(s) targeted: Soft Tissue Infections

Intervention: beta-lactam (Drug); beta-lactam (Drug); Standard care (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical cure rate.

Secondary outcome:

Time to clinical cure

Time to resolution of signs and symptoms of skin or soft tissue infection

Bacteriological outcome

Adverse events; laboratory abnormalities

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

ROSARIO 2000, Argentina

CÓRDOBA X5004CDT, Argentina

SANTA FE 3000, Argentina

CÓRDOBA 5000, Argentina

BUENOS AIRES 1888, Argentina

BUENOS AIRES 1657, Argentina

GRANADERO BAIGORRIA 2152, Argentina

ROSARIO S2000DSV, Argentina

BUENOS AIRES 1282, Argentina

PALOMAR 1684, Argentina

BUENOS AIRES 1430, Argentina

CIUDADELA 1702, Argentina

PARANA 3100, Argentina

NEUQUEN 8300, Argentina

SOFIA 1606, Bulgaria

VARNA 9000, Bulgaria

PLEVEN 5800, Bulgaria

PLOVDIV 4002, Bulgaria

TALLINN 13419, Estonia

TALLINN 11312, Estonia

TARTU 51014, Estonia

MÜNCHEN 81377, Germany

MAINZ 55131, Germany

LÜBECK 23538, Germany

BUDAPEST 1076, Hungary

BUDAPEST H-1082, Hungary

RIGA 1002, Latvia

RIGA 1001, Latvia

RIGA 1038, Latvia

LIEPAJA 3402, Latvia

KAUNAS 50009, Lithuania

VILNIUS 08661, Lithuania

KLAIPEDA 92288, Lithuania

VILNIUS 04130, Lithuania

VILNIUS 10207, Lithuania

LIMA 13, Peru

LIMA 11, Peru

LIMA 1, Peru

LIMA, Peru

CLUJ-NAPOCA 400006, Romania

TIRGU-MURES 540342, Romania

BUCHAREST 014461, Romania

BUCHAREST 041914, Romania

CONSTANTA 900591, Romania

TEMBA 0040, South Africa

PORT ELIZABETH 6020, South Africa

MIDDLEBURG 1050, South Africa

PRETORIA 0082, South Africa

SOMMERSET WEST 7130, South Africa

BENONI 1501, South Africa

CAPE TOWN 7530, South Africa

MOBILE, Alabama 36608, United States

BIRMINGHAM, Alabama 35209, United States

MIAMI BEACH, Florida 33139, United States

DETROIT, Michigan 48202-2689, United States

MINNEAPOLIS, Minnesota 55422, United States

WINSTON-SALEM, North Carolina 27103, United States

Ending date: October 2007
Last updated: June 17, 2008