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

NCT01591863 — Phase 2, Completed, 38 participants, Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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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)

RegistryNCT01591863
StatusCompleted
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment38 (Actual)
SponsorOptimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (Industry)
ConditionsClostridium Difficile-associated Diarrhea
Interventionsfidaxomicin (Drug)
Datesstart 2012-06-15, primary completion 2014-03-07, completion 2014-03-07, first posted 2012-05-04, last updated 2018-09-18

Related Papers Related Patents Related Grants Related Experts
All trials for Clostridium Difficile-associated Diarrhea All trials of fidaxomicin

-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).

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+Arms and interventions

ArmTypeInterventionsDescription
fidaxomicinExperimentalDrug: fidaxomicin
  • fidaxomicin (Drug), also known as Dificid, Dificlir, OPT-80, PAR-101: 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.

+Outcome measures

Primary outcomes

  • Number of Participants With Adverse Events. [Enrollment through end of study (Day 38-41)]: Number of participants with adverse events, as categorized by MedDRA.
  • Investigate Concentrations of Fidaxomicin in Plasma Samples. [3-5 hours after administration]: 3-5 hour plasma levels of fidaxomicin (mean)
  • Investigate Concentrations of Fidaxomicin in Fecal Samples. [End of Therapy; Day 10-11]: End of therapy fecal levels of fidaxomicin (mean)
  • Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples. [3-5 hours after administration]: 3-5 hour plasma levels of OP-1118 (mean)
  • Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples. [End of Therapy; Day 10-11]: End of therapy fecal levels of OP-1118 (mean)

Secondary outcomes

  • Evaluate the Clinical Outcome by Assessment of Clinical Response. [Day 10]: Positive clinical response defined as resolution of diarrhea
  • Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response. [28 days post-treatment]: Positive clinical response without recurrence through the follow-up period

+Eligibility

Sex: All, ages: 6 Months to 18 Years

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

+Posted results

Participant flow

MilestoneFidaxomicin
Started38
Completed24
Not completed14

Outcome results

  • Number of Participants With Adverse Events. (Primary), Number, participants: Fidaxomicin 28
  • Investigate Concentrations of Fidaxomicin in Plasma Samples. (Primary), Mean, ng/mL: Fidaxomicin 13.363 +/- 15.472
  • Investigate Concentrations of Fidaxomicin in Fecal Samples. (Primary), Mean, microgram/g: Fidaxomicin 3227.93 +/- 2668.08
  • Evaluate the Clinical Outcome by Assessment of Clinical Response. (Secondary), Number, percentage of subjects: Fidaxomicin 92.1 (83.5 to 100)
  • Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response. (Secondary), Number, percentage of participants: Fidaxomicin 65.8 (50.7 to 80.9)
  • Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples. (Primary), Mean, ng/mL: Fidaxomicin 60.016 +/- 152.196
  • Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples. (Primary), Mean, microgram/g: Fidaxomicin 865.49 +/- 614.15

Adverse events

Time frame: From informed consent through 30 days after the last administration of study treatment.

ArmDeathsSerious adverse eventsOther adverse events
Fidaxomicin09/38 (23.7%)17/38 (44.7%)

Serious adverse events by term

TermOrgan systemFidaxomicin
Clostridium difficilie colitisInfections and infestations3/38
febrile neutropeniaBlood and lymphatic system disorders1/38
HematemesisGastrointestinal disorders1/38
vomitingGastrointestinal disorders2/38
adenovirus infectionInfections and infestations1/38
clostridial infectionInfections and infestations1/38
septic shockInfections and infestations1/38
gastrostomy failureInjury, poisoning and procedural complications1/38
respiratory failureRespiratory, thoracic and mediastinal disorders1/38

Other adverse events by term

TermOrgan systemFidaxomicin
abdominal pain upperGastrointestinal disorders3/38
constipationGastrointestinal disorders2/38
diarrheaGastrointestinal disorders2/38
nauseaGastrointestinal disorders2/38
oesophagitisGastrointestinal disorders2/38
vomitingGastrointestinal disorders3/38
chest painGeneral disorders2/38
pyrexiaGeneral disorders4/38
nasopharyngitisInfections and infestations2/38
dehydrationMetabolism and nutrition disorders2/38
headacheNervous system disorders2/38
urticariaSkin and subcutaneous tissue disorders2/38
hypertensionVascular disorders2/38

+Publications

  • Results publication: 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

+Investigators

  • Medical Director, Study director, Merck Sharp & Dohme LLC