Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any - 18
Updated:3/1/2014
Start Date:June 2012
End Date:January 2014
Contact:Mara Lee
Email:maralee@optimerpharma.com
Phone:858-427-3298

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A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).


Inclusion Criteria:

- Male or female 6 months to 17 years 11 months of age, inclusive;

- Female subjects of childbearing potential must use adequate contraception

- Diagnosed with CDAD

Exclusion Criteria:

- Concurrent use of oral vancomycin or metronidazole or any other effective treatments
for CDAD

- Fulminant colitis

- History of inflammatory bowel disease

- Pregnant or breast-feeding

- Need for concurrent use of some P-glycoprotein inhibitors during therapy
We found this trial at
14
sites
570
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Salt Lake City, UT
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Aurora, CO
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Baltimore, MD
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Chicago, IL
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Cleveland, OH
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Indianapolis, IN
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Los Angeles, CA
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Louisville, KY
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Morristown, NJ
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Pittsburgh, PA
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Stony Brook, NY
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2281
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Washington,
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