Research

Clostridium Difficile-Associated Diarrhea Treatment with Fidaxomicin – Phase IIa

Study to Determine the Safety, Tolerability and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects with Clostridium difficile-associated Diarrhea (CDAD)

Protocol Description

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.

Study Level: Phase IIa

Eligibility Criteria

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

Requirements
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

Status: Open for Enrollment

Source(s) of Support
Optimer Pharmaceuticals, Inc.

Additional Information
Study description at National Institutes of Health