Back to resultsA Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
Primary Purpose
Soft Tissue Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Standard care
beta-lactam
beta-lactam
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Infections
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Clinical cure rate.
Secondary Outcome Measures
Time to clinical cure
Time to resolution of signs and symptoms of skin or soft tissue infection
Bacteriological outcome
Adverse events; laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00303589
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Standard care
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
beta-lactam
Intervention Description
750mg iv q8h
Intervention Type
Drug
Intervention Name(s)
beta-lactam
Intervention Description
1500mg iv q8h
Primary Outcome Measure Information:
Title
Clinical cure rate.
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Time to clinical cure
Time Frame
Event driven
Title
Time to resolution of signs and symptoms of skin or soft tissue infection
Time Frame
Event driven
Title
Bacteriological outcome
Time Frame
Event driven
Title
Adverse events; laboratory abnormalities
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Buenos Aires
ZIP/Postal Code
1282
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1657
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1888
Country
Argentina
City
Ciudadela
ZIP/Postal Code
1702
Country
Argentina
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
City
Córdoba
ZIP/Postal Code
X5004CDT
Country
Argentina
City
Entre Rios
ZIP/Postal Code
3100
Country
Argentina
City
Granadero Baigorria
ZIP/Postal Code
2152
Country
Argentina
City
Merlo
ZIP/Postal Code
1722
Country
Argentina
City
Neuquen
ZIP/Postal Code
8300
Country
Argentina
City
Palomar
ZIP/Postal Code
1684
Country
Argentina
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000DSV
Country
Argentina
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
München
ZIP/Postal Code
81377
Country
Germany
City
Münster
ZIP/Postal Code
48157
Country
Germany
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1082
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Liepaja
ZIP/Postal Code
3402
Country
Latvia
City
Riga
ZIP/Postal Code
1001
Country
Latvia
City
Riga
ZIP/Postal Code
1002
Country
Latvia
City
Riga
ZIP/Postal Code
1038
Country
Latvia
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
04130
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
City
Vilnius
ZIP/Postal Code
10207
Country
Lithuania
City
La Victoria, Lima
ZIP/Postal Code
Lima 13
Country
Peru
City
Lima
ZIP/Postal Code
11
Country
Peru
City
Lima
ZIP/Postal Code
1
Country
Peru
City
Lima
Country
Peru
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
City
Bucharest
ZIP/Postal Code
041914
Country
Romania
City
Cluj-napoca
ZIP/Postal Code
400006
Country
Romania
City
Constanta
ZIP/Postal Code
900591
Country
Romania
City
Tirgu-mures
ZIP/Postal Code
540342
Country
Romania
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
City
Middleburg
ZIP/Postal Code
1050
Country
South Africa
City
Port Elizabeth
ZIP/Postal Code
6020
Country
South Africa
City
Pretoria
ZIP/Postal Code
0082
Country
South Africa
City
Sommerset West
ZIP/Postal Code
7130
Country
South Africa
City
Temba
ZIP/Postal Code
0040
Country
South Africa
12. IPD Sharing Statement
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A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
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