Trial Information
Summary: Linezolid Vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients with Catheter-Related Gram-Positive Bloodstream Infections [A5951105]
The purpose of this research study is to find out if linezolid
works in the treatment of catheter-related gram-positive infections
in the bloodstream and that the treatment is safe. Linezolid (the
study medication) will be compared to vancomycin/cefazolin (which
are common treatments used for this infection). Linezolid,
vancomycin and cefazolin are available by prescription and are
approved for use by the FDA. However, none of these medications
have been approved for the treatment of this type of
infection.
Half of the patients will receive treatment with linezolid and half
will receive treatment with vancomycin/cefazolin. Participation
will last for a maximum of 84 days and patients may receive
treatment with the study medication for up to 28 days.
All study procedures and medications will be provided at no
cost.
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
You may be eligible to participate if you
-are 18 years old or older
-are on hemodialysis
-have end stage renal disease
-have a catheter-related infection OR a fever OR a gram-positive
blood culture
-meet additional criteria
You will not be able to participate if you
-are pregnant or breastfeeding
-have an infected catheter that cannot be removed
-have evidence of other infections
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Contact:
Gabrielle Gaspard, research coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Telephone: 212-241-0059
Fax: 212-987-0389
Email:
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Trial listings updated: June 1, 2008 at 5:44:54 AM