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

Clostridium Difficile-associated Diarrhea Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591863
• Other study ID #: 5119-010
• Secondary ID: OPT-80-206
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2012
• Est. completion date: March 7, 2014

Study information

• Verified date: August 2018
• Source: Optimer Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 7, 2014
• Est. primary completion date: March 7, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile-associated Diarrhea
• Diarrhea

Intervention

Drug:
• fidaxomicin
6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days. 6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Optimer Pharmaceuticals LLC

References & Publications (1)

O'Gorman MA, Michaels MG, Kaplan SL, Otley A, Kociolek LK, Hoffenberg EJ, Kim KS, Nachman S, Pfefferkorn MD, Sentongo T, Sullivan JE, Sears P. Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Ph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events.	Number of participants with adverse events, as categorized by MedDRA.	Enrollment through end of study (Day 38-41)
Primary	Investigate Concentrations of Fidaxomicin in Plasma Samples.	3-5 hour plasma levels of fidaxomicin (mean)	3-5 hours after administration
Primary	Investigate Concentrations of Fidaxomicin in Fecal Samples.	End of therapy fecal levels of fidaxomicin (mean)	End of Therapy; Day 10-11
Primary	Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.	3-5 hour plasma levels of OP-1118 (mean)	3-5 hours after administration
Primary	Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.	End of therapy fecal levels of OP-1118 (mean)	End of Therapy; Day 10-11
Secondary	Evaluate the Clinical Outcome by Assessment of Clinical Response.	Positive clinical response defined as resolution of diarrhea	Day 10
Secondary	Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.	Positive clinical response without recurrence through the follow-up period	28 days post-treatment