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

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.

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Infections
• Intervention / Treatment: Drug: beta-lactam; Drug: beta-lactam; Drug: Standard care

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1282
  • Buenos Aires, Argentina, 1430
  • Buenos Aires, Argentina, 1657
  • Buenos Aires, Argentina, 1888
  • Ciudadela, Argentina, 1702
  • Córdoba, Argentina, 5000
  • Córdoba, Argentina, X5004CDT
  • Entre Rios, Argentina, 3100
  • Granadero Baigorria, Argentina, 2152
  • Merlo, Argentina, 1722
  • Neuquen, Argentina, 8300
  • Palomar, Argentina, 1684
  • Rosario, Argentina, 2000
  • Rosario, Argentina, S2000DSV
  • Santa Fe, Argentina, 3000
• Bulgaria
  • Pleven, Bulgaria, 5800
  • Plovdiv, Bulgaria, 4002
  • Sofia, Bulgaria, 1606
  • Varna, Bulgaria, 9000
• Estonia
  • Tallinn, Estonia, 11312
  • Tallinn, Estonia, 13419
  • Tartu, Estonia, 51014
• Germany
  • Lübeck, Germany, 23538
  • Mainz, Germany, 55131
  • München, Germany, 81377
  • Münster, Germany, 48157
• Hungary
  • Budapest, Hungary, 1076
  • Budapest, Hungary, H-1082
  • Gyor, Hungary, 9024
• Latvia
  • Liepaja, Latvia, 3402
  • Riga, Latvia, 1002
  • Riga, Latvia, 1038
  • Riga, Latvia, 1001
• Lithuania
  • Kaunas, Lithuania, 50009
  • Klaipeda, Lithuania, 92288
  • Vilnius, Lithuania, 08661
  • Vilnius, Lithuania, 10207
  • Vilnius, Lithuania, 04130
• Peru
  • La Victoria, Lima, Peru, Lima 13
  • Lima, Peru
  • Lima, Peru, 11
  • Lima, Peru, 1
• Romania
  • Bucharest, Romania, 014461
  • Bucharest, Romania, 041914
  • Cluj-napoca, Romania, 400006
  • Constanta, Romania, 900591
  • Tirgu-mures, Romania, 540342
• South Africa
  • Benoni, South Africa, 1501
  • Cape Town, South Africa, 7530
  • Middleburg, South Africa, 1050
  • Port Elizabeth, South Africa, 6020
  • Pretoria, South Africa, 0082
  • Sommerset West, South Africa, 7130
  • Temba, South Africa, 0040
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
    • Mobile, Alabama, United States, 36608
  • Florida
    • Melbourne, Florida, United States, 32901
    • Miami Beach, Florida, United States, 33139
  • Michigan
    • Detroit, Michigan, United States, 48201
    • Detroit, Michigan, United States, 48202-2689
  • Minnesota
    • Minneapolis, Minnesota, United States, 55422
  • North Carolina
    • Winston-salem, North Carolina, United States, 27103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: beta-lactam; 750mg iv q8h; Drug: beta-lactam; 1500mg iv q8h
Experimental: 2	Drug: beta-lactam; 750mg iv q8h; Drug: beta-lactam; 1500mg iv q8h
Active Comparator: 3	Drug: Standard care; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical cure rate.	Event driven

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to clinical cure	Event driven
Time to resolution of signs and symptoms of skin or soft tissue infection	Event driven
Bacteriological outcome	Event driven
Adverse events; laboratory abnormalities	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: March 16, 2006
• First Submitted That Met QC Criteria: March 16, 2006
• First Posted (Estimate): March 17, 2006

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Soft Tissue Infections; Anti-Infective Agents; Anti-Bacterial Agents; Lactams; beta-Lactams
• Other Study ID Numbers: WI18274