Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections



Status:Recruiting
Conditions:Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:February 20, 2018
End Date:November 2019
Contact:Kamal Hamed, MD, MPH
Email:kamal.hamed@basilea.com
Phone:+41 61 567 15 88

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A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections

The purpose of this study is to compare the safety and efficacy of ceftobiprole medocaril
versus vancomycin plus aztreonam in the treatment of patients with acute bacterial skin and
skin structure infections.


Inclusion Criteria:

- Male or female ≥18 years of age

- Diagnosis of acute bacterial skin and skin structure infection (ABSSSI), with a
regional or systemic sign of infection

- Requirement for intravenous bacterial treatment

Exclusion Criteria:

- Use of any systemic antibacterial treatment within 14 days

- Contraindication to the administration of the study treatments, including known
clinically-relevant hypersensitivity

- Uncomplicated skin and skin structure infection

- Primary ABSSSI due to or associated with any of the following: diabetic foot
infection, gangrene, or perianal abscess; concomitant infection at another site;
infected burns; decubitus, chronic, or ischemic ulcer; evolving necrotizing process;
infections at vascular catheter sites or involving thrombophlebitis

- Requirement for more than two surgical interventions in the operating room

- Severe sepsis or septic shock
We found this trial at
16
sites
501 South Buena Vista Street
Anaheim, California 92804
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Anaheim, California 92804
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Butte, Montana 59701
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Chula Vista, California 91911
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Florida City, Florida 33134
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Fresno, California 93721
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17822 Beach Boulevard
huntington beach, California 92647
(714) 375-5970
Marvel Clinical Research is a dedicated research site coupled with multi-speciality and family practice doctors...
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La Mesa, California 91942
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La Palma, California 90623
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Las Vegas, Nevada 89109
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3059 South Maryland Parkway
Las Vegas, Nevada 89109
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Long Beach, California 90806
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Long Beach, California 90804
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Long Beach, CA
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Miami, FL
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Modesto, California 95350
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Modesto, CA
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