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This multicenter study is being done to learn more about the safety and effects of the drug fidaxomicin when given for the treatment of CDAD, which is diarrhea resulting from an infection by bacteria called Colostridium difficile. This medicine was recently approved for use by adults, but has not yet been approved for use by children.
Subject to certain exclusion criteria, this study is open to infants, children and teens through age 17, who are diagnosed with CDAD.
Males and Females: Ages 6 months through 17 years
Participants will be given an initial screening examination inclusive of bloodwork, urine and stool sampling and an electrocardiogram. Weight-based dosages will be prescribed – either liquid (generally for infants and toddlers) or tablet – to be taken twice a day for 10 days. Parents will be contacted daily by telephone during the treatment period. An additional visit is required during the treatment period, again at the conclusion of treatment and one more time 28 days later.
Visits: 4 with ongoing telephone follow-up
Duration: 38 days
Optimer Pharmaceuticals, Inc.
Study description at National Institutes of Health
Judith Martin, MD
For enrollment information, please contact:
Diane Gwin, RN, BSN, MSN, CCRC
Noreen Jeffrey, RN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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