This is a multinational research study comparing liquid or tablets of medicine Fidaxomicin versus liquid or capsules of medicine Vancomycin in children having Diarrhea caused with bacteria named Clostridium difficile

• Register: EUCTR
• Last refreshed on: 28 May 2018
• Main ID: EUCTR2013-000508-40-BE
• Date of registration: 07/08/2014
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: This is a multinational research study comparing liquid or tablets of medicine Fidaxomicin versus liquid or capsules of medicine Vancomycin in children having Diarrhea caused with bacteria named Clostridium difficile
• Scientific title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects with Clostridium difficile-associated Diarrhea
• Date of first enrolment: 29/09/2014
• Target sample size: 144
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000508-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: yes; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovakia, Spain, United States

Contacts

• Name: Service Desk - Gobal Clinical Dev't
• Affiliation: Astellas Pharma Europe B.V.

• Name: Service Desk - Gobal Clinical Dev't
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent/ assent ( if applicable) and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2. Male and female subjects aged = 6 monthsfrom birth to < 18 years of age. Note that in the United Statesof America subjects can only be included if aged = 6 months to < 18 years.
3.Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum there must be positive detection, within 72 hours prior to randomization, of either toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in stool and:
a.Subject = 6 monthsfrom birth to < 2 years: watery diarrhea in the 24 hours prior to screening.
b.Subject = 2 years to < 18 years: > 3 unformed bowel movements in the 24 hours prior to screening.
4. For subjects < 5 years: Negative rotavirus test.
5. Female subject of childbearing potential:
a. must have a negative urine pregnancy test at Screening, and
b. must abstain from sexual activity for the duration of the study, or
c. must use two forms of birth control* (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
6. Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
7. Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
8. Subject agrees not to participate in another interventional study while in the study (with the exception of studies as described in exclusion criteria 6).
Are the trial subjects under 18? yes
Number of subjects for this age range: 144
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments for CDAD. If the investigator feels the clinical imperative is to begin treatment before knowing the laboratory result for toxigenic C. difficile, up to four doses but no more than 24 hours of treatment with metronidazole, oral vancomycin or any other effective treatment for CDAD are allowed.
2. Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.
3. Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or Crohn?s disease etc.).
4. Subject has diarrhea caused by an agent other than C. difficile (e.g. infections, infestations, drugs etc.).
5. Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or to teicoplanin.
6. Subject has received an investigational therapy within 28 days, prior to Screening, with the exception of studies with primary treatment for cancer without novel Investigational Medicinal
Product (IMP) and which do not affect the assessment of diarrhea.
7. Subject has a condition which, in the investigator?s opinion, makes the subject unsuitable for study participation.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of enterocolitis caused by Clostridium difficile
MedDRA version: 18.0 Level: LLT Classification code 10012734 Term: Diarrhea, Clostridium difficile System Organ Class: 100000004862

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Product Name: fidaxomicin
Product Code: fidaxomicin
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: FIDAXOMICIN
CAS Number: 873857-62-6
Current Sponsor code: FIDAXOMICIN
Other descriptive name: FIDAXOMICIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Trade Name: Dificlir
Product Name: Dificlir
Product Code: Dificlir
Pharmaceutical Form: Tablet
INN or Proposed INN: FIDAXOMICIN
CAS Number: 873857-62-6
Current Sponsor code: FIDAXOMICIN
Other descriptive name: FIDAXOMICIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Vancomicina Hospira
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: VANCOMYCIN HYDROCHLORIDE
CAS Number: 1404-90-6
Current Sponsor code: VANCOMYCIN HYDROCHLORIDE
Other descriptive name: VANCOMYCIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Vancomycin Capsules 125 MG
Pharmaceutical Form: Capsule
INN or Proposed INN: VANCOMYCIN HYDROCHLORIDE
CAS Number: 1404-90-6
Current Sponsor code: VANCOMYCIN HYDROCHLORIDE
Other descriptive name: VANCOMYCIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Primary Outcome(s)

Primary end point(s): Confirmed clinical response based on the assessment by the investigator at EOT+2 days TC/visit

Main Objective: The primary objective of this study is to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules of pediatric subjects with Clostridium difficile-associated diarrhea (CDAD) from birth to < 18 years of age.

Secondary Objective: The secondary objectives of this study are to investigate the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD) from birth to < 18 years of age, as well as acceptance of the fidaxomicin oral suspension formulation.

Timepoint(s) of evaluation of this end point: at EOT+2 days TC/visit

Secondary Outcome(s)

Secondary end point(s): Efficacy
- Sustained clinical response at the EOS (EOT visit+30 days)
- Sustained clinical response 14 days after Confirmation Clinical Response TC/visit (EOT visit+16 days)
- Time to resolution of diarrhea (TTROD)
- Recurrence of CDAD during or at the end of the Follow-up period
- Time to recurrence during or at the end of the Follow-up period
Safety:
The safety evaluation will include adverse events, clinical laboratory tests (hematology, biochemistry and urinalysis), vital signs and ECGs.
Drug concentration measurement:
• Plasma concentrations of fidaxomicin and its main metabolite (OP-1118) within 30 minutes pre-dose and 1 to 5 hours post-dose taken between Day 5 and 10, inclusive.
• Fecal concentration of fidaxomicin and its main metabolite (OP-1118) within 24 hours of a dose taken between Day 5 and 10, inclusive.
Palatability:
Acceptance of formulation at first administration of study drug and at Day 7 (± 1 day) in all subjects receiving fidaxomicin oral suspension or vancomycin oral liquid.

Timepoint(s) of evaluation of this end point: Efficacy
- EOS (EOT visit+30 days)
- EOT visit+16 days
- Throughout the study including follow up period
Safety
- daily assesments: -2,1,2-4,5-10,10, EOT+2, EOT+9, 16&23, EOT+30

Secondary ID(s)

2013-000508-40-DE

2819-CL-0202

Source(s) of Monetary Support

Astellas Pharma Europe B.V.