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

NCT ID: NCT00303589

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

beta-lactam

Intervention Type DRUG

750mg iv q8h

2

Group Type EXPERIMENTAL

beta-lactam

Intervention Type DRUG

1500mg iv q8h

3

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type DRUG

As prescribed

Interventions

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Standard care

As prescribed

Intervention Type DRUG

beta-lactam

750mg iv q8h

Intervention Type DRUG

beta-lactam

1500mg iv q8h

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Melbourne, Florida, United States

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Miami Beach, Florida, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Winston-Salem, North Carolina, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Ciudadela, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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El Palomar, , Argentina

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Entre Ríos, , Argentina

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Granadero Baigorria, , Argentina

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Merlo, , Argentina

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Neuquén, , Argentina

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Rosario, , Argentina

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Rosario, , Argentina

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Santa Fe, , Argentina

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Lübeck, , Germany

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Mainz, , Germany

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München, , Germany

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Münster, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Győr, , Hungary

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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La Victoria, Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Constanța, , Romania

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Târgu Mureş, , Romania

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Benoni, , South Africa

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Cape Town, , South Africa

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Middleburg, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Sommerset West, , South Africa

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Themba, , South Africa

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Countries

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

Other Identifiers

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WI18274

Identifier Type: -

Identifier Source: org_study_id