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

Soft Tissue Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303589
• Other study ID #: WI18274
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2006
• Last updated: November 1, 2016
• Start date: December 2005
• Est. completion date: October 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Soft Tissue Infections

Intervention

Drug:
• Standard care
As prescribed
• beta-lactam
750mg iv q8h
• beta-lactam
1500mg iv q8h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Estonia,  Germany,  Hungary,  Latvia,  Lithuania,  Peru,  Romania,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate.		Event driven	No
Secondary	Time to clinical cure		Event driven	No
Secondary	Time to resolution of signs and symptoms of skin or soft tissue infection		Event driven	No
Secondary	Bacteriological outcome		Event driven	No
Secondary	Adverse events; laboratory abnormalities		Throughout study	No