Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:June 1, 2018
End Date:August 2021
Contact:Kamal Hamed, MD, MPH
Email:kamal.hamed@basilea.com
Phone:+41 61 567 15 88

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A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis

The purpose of this study is to compare the efficacy and safety of ceftobiprole medocaril
versus a comparator in the treatment of patients with complicated Staphylococcus aureus
bacteremia.


Inclusion Criteria:

- Male or female ≥ 18 years of age

- Staphylococcus aureus bacteremia (SAB), based on at least one positive blood culture
obtained within the 72 h prior to randomization

- At least two of the following signs or symptoms of bacteremia:

1. fever ≥ 38°C/100.4°F

2. white blood cell count > 10,000 or < 4,000 cells/µL, or > 10% immature
neutrophils (bands)

3. tachycardia (heart rate > 90 bpm)

4. hypotension (systolic blood pressure < 90 mmHg)

- At least one of the following:

1. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal
dialysis

2. Persistent SAB

3. Definite native-valve right-sided infective endocarditis by Modified Duke's
Criteria

4. Other forms of complicated SAB

- Other inclusion criteria may apply

Exclusion Criteria:

- Treatment with potentially effective (anti-staphylococcal) systemic antibacterial
treatment for more than 48 h within the 7 days prior to randomization; Exception:
Documented failure of bloodstream clearance

- Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that
are known to be non-susceptible to either ceftobiprole or aztreonam

- Left-sided infective endocarditis

- Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic
implantable cardioverter-defibrillator, or left-ventricular assist devices

- Community- or hospital-acquired pneumonia

- Opportunistic infections within 30 days prior to randomization, where the underlying
cause of these infections is still active

- Requirement for continuous renal-replacement therapy

- Women who are pregnant or nursing

- Other exclusion criteria may apply
We found this trial at
9
sites
Butte, Montana 59701
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Butte, MT
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Blagoevgrad,
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Chula Vista, California 91911
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Chula Vista, CA
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Columbus, Ohio 43214
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Columbus, OH
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Coral Gables, Florida 33134
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Coral Gables, FL
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La Mesa, California 91942
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La Mesa, CA
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Las Vegas, Nevada 89109
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Las Vegas, NV
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Mobile, Alabama 36608
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Mobile, AL
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West Palm Beach, Florida 33401
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West Palm Beach, FL
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