Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea



Status:Completed
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:5/26/2018
Start Date:December 12, 2013
End Date:May 2, 2017

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A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD).

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
in subjects with Clostridium difficile-associated diarrhea (CDAD).

Subjects selected to participate in the study are treated either with cadazolid or vancomycin
for 10 days. At the end of treatment, clinical cure is assessed; subjects are then
followed-up to assess any disease recurrence.

Inclusion Criteria:

- Signed Informed Consent.

- Male or female ≥ 18 years of age. Females of childbearing potential must agree to use
an adequate and reliable method of contraception.

- Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first
recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid
or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive
C. difficile toxin test on a stool sample produced within 72 hours prior to
randomization.

Exclusion Criteria:

- More than one previous episode of CDAD in the 3-month period prior to randomization.

- Evidence of life-threatening or fulminant CDAD.

- Likelihood of death within 72 hours from any cause.

- History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.

- Antimicrobial treatment active against CDAD administered for > 24 hours except for
metronidazole treatment failures (MTF)

- Known hypersensitivity or contraindication to study drugs, oxazolidinones, or
quinolones.

- Unable or unwilling to comply with all protocol requirements.

- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol
We found this trial at
41
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Stuart, FL
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Annandale, VA
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Annapolis, MD
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Birmingham, AL
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Bowling Green, KY
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Brooklyn, NY
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Butte, MT
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Chicago, IL
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Cincinnati, OH
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Cordoba,
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Cypress, TX
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Dallas, TX
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Detroit, MI
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Detroit, MI
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Fayetteville, North Carolina 28304
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Fayetteville, NC
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Framingham, Massachusetts 01702
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Framingham, MA
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Houston, TX
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Houston, TX
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Jackson, MS
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Jacksonville, North Carolina 28546
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Jacksonville, NC
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Kinston, NC
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Laguna Hills, CA
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Lewiston, ME
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Marietta, GA
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Marshfield, WI
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Mentor, OH
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Mission Hills, California 91345
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Mission Hills, CA
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Monroeville, PA
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New Orleans, LA
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Orlando, FL
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Philadelphia, PA
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Port Saint Lucie, FL
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Rialto, CA
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Saint Paul, MN
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Shreveport, LA
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Toledo, OH
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Wenatchee, WA
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561
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West Jordan, UT
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2303
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Weston, FL
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