Clinical trial NCT00303589: A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical cure rate.
timeFrame: Event driven
Secondary outcomes:
measure: Time to clinical cure
timeFrame: Event driven
measure: Time to resolution of signs and symptoms of skin or soft tissue infection
timeFrame: Event driven
measure: Bacteriological outcome
timeFrame: Event driven
measure: Adverse events; laboratory abnormalities
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Melbourne
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Winston-salem
country: United States
state: North Carolina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Ciudadela
country: Argentina
city: Córdoba
country: Argentina
city: Córdoba
country: Argentina
city: Entre Rios
country: Argentina
city: Granadero Baigorria
country: Argentina
city: Merlo
country: Argentina
city: Neuquen
country: Argentina
city: Palomar
country: Argentina
city: Rosario
country: Argentina
city: Rosario
country: Argentina
city: Santa Fe
country: Argentina
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Lübeck
country: Germany
city: Mainz
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: La Victoria, Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Tirgu-mures
country: Romania
city: Benoni
country: South Africa
city: Cape Town
country: South Africa
city: Middleburg
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Sommerset West
country: South Africa
city: Temba
country: South Africa
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: