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

NCT01591863 | Completed Phase 2 Results DMC

• 2 other identifiers: 5119-010OPT-80-206
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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

Keywords

Clostridium difficile-associated diarrhea; CDAD; Pediatric

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events.

  Number of participants with adverse events, as categorized by MedDRA.

  Enrollment through end of study (Day 38-41)

• Investigate Concentrations of Fidaxomicin in Plasma Samples.

  3-5 hour plasma levels of fidaxomicin (mean)

  3-5 hours after administration

• Investigate Concentrations of Fidaxomicin in Fecal Samples.

  End of therapy fecal levels of fidaxomicin (mean)

  End of Therapy; Day 10-11

• 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

• 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 Outcomes (2)

• Evaluate the Clinical Outcome by Assessment of Clinical Response.

  Day 10

• Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.

  28 days post-treatment

Study Arms (1)

fidaxomicin

EXPERIMENTAL

Drug: fidaxomicin

Interventions

fidaxomicin 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.

Also known as: Dificid, Dificlir, OPT-80, PAR-101

fidaxomicin

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

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

  PMID: 28575523 RESULT

MeSH Terms

Interventions

Fidaxomicin; OPT 80

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 4, 2012
• Study Start: June 15, 2012
• Primary Completion: March 7, 2014
• Study Completion: March 7, 2014
• Last Updated: September 18, 2018
• Results First Posted: March 17, 2015

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share