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Completed

NCT Number: NCT01591863

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

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

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Key information

Conditions

Clostridium Difficile-associated Diarrhea

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dificid, Dificlir, OPT-80, PAR-101

Primary outcomes

  1. Number of Participants With Adverse Events.

    Time frame: Enrollment through end of study (Day 38-41)

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

  2. Investigate Concentrations of Fidaxomicin in Plasma Samples.

    Time frame: 3-5 hours after administration

    3-5 hour plasma levels of fidaxomicin (mean)

  3. Investigate Concentrations of Fidaxomicin in Fecal Samples.

    Time frame: End of Therapy; Day 10-11

    End of therapy fecal levels of fidaxomicin (mean)

  4. Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.

    Time frame: 3-5 hours after administration

    3-5 hour plasma levels of OP-1118 (mean)

  5. Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.

    Time frame: End of Therapy; Day 10-11

    End of therapy fecal levels of OP-1118 (mean)

Secondary outcomes

  1. Evaluate the Clinical Outcome by Assessment of Clinical Response.

    Time frame: Day 10

    Positive clinical response defined as resolution of diarrhea

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

    Time frame: 28 days post-treatment

    Positive clinical response without recurrence through the follow-up period

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 4, 2012
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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