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

NCT ID: NCT01591863

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-15
• Study Completion Date: 2014-03-07

Brief 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).

Conditions

Clostridium Difficile-associated Diarrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fidaxomicin

Group Type: EXPERIMENTAL

fidaxomicin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Dificid, Dificlir, OPT-80; PAR-101

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 Phase 2a Multicenter Clinical Trial. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):210-218. doi: 10.1093/jpids/pix037.

Reference Type: RESULT

PMID: 28575523 (View on PubMed)

Other Identifiers

OPT-80-206

Identifier Type: OTHER

Identifier Source: secondary_id

5119-010

Identifier Type: -

Identifier Source: org_study_id