Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:March 8, 2007
End Date:March 3, 2015

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A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

The purpose of the study is to compare the safety and efficacy of isavuconazole versus
caspofungin followed by voriconazole in the treatment of candidemia and other invasive
Candida infections.

Candida infections, representing approximately 80% of all major systemic fungal infections,
are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate
of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study
investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are
randomized to isavuconazole and the reference regimen. Patients with a positive blood- or
deep tissue culture of candida fungi can be included.

Inclusion Criteria:

- Patients with candidemia or with an invasive Candida infection

- Presence of fever, hypothermia or other appropriate local sign of infection

- Female patients must be non-lactating and at no risk of pregnancy

Exclusion Criteria:

- Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal,
esophageal or genital candidiasis; or candidal lower urinary tract infection or
Candida isolated solely from respiratory tract specimens

- Patients with candidemia who failed a previous antifungal therapy for the same
infection

- Patients previously enrolled in a phase III study with isavuconazole

- Patients with a body weight <40kg
We found this trial at
19
sites
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
1965
mi
from 91732
Detroit, MI
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
1777
mi
from 91732
Birmingham, AL
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
2301
mi
from 91732
Baltimore, MD
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Butte, Montana 59701
873
mi
from 91732
Butte, MT
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6113
mi
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Capital Federal,
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Idaho Falls, Idaho 83404
721
mi
from 91732
Idaho Falls, ID
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Indianapolis, Indiana 46280
1793
mi
from 91732
Indianapolis, IN
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1904
mi
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Lima, OH
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Maywood, Illinois 60153
1718
mi
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Maywood, IL
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Neptune, New Jersey 07754
2433
mi
from 91732
Neptune, NJ
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New Orleans, Louisiana 70121
1650
mi
from 91732
New Orleans, LA
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New York, New York 10032
2435
mi
from 91732
New York, NY
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Palm Desert, California 92211
97
mi
from 91732
Palm Desert, CA
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Philadelphia, Pennsylvania 19140
2375
mi
from 91732
Philadelphia, PA
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363
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Sacramento, CA
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San Francisco, California 94143
356
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San Francisco, CA
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Springfield, Illinois 62703
1608
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from 91732
Springfield, IL
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
2129
mi
from 91732
Winston-Salem, NC
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Worcester, Massachusetts 01605
2541
mi
from 91732
Worcester, MA
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