A study in which the blood levels of the antibiotic fidaxomicin are studied in patients with an inflammation of the intestine and concomitantly an infection of the gut caused by bacteria called Clostridium difficile.

Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) - PROFILE

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003002-32-CZ

Enrollment

Registered

2015-02-19

Start date

2015-05-05

Completion date

Unknown

Last updated

2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD) MedDRA version: 18.0 Level: LLT Classification code 10022661 Term: Intestinal infection due to clostridium difficile System Organ Class: 100000004862

Interventions

Trade Name: Dificlir Product Name: DIFICLIR 200 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: fidaxomicin CAS Number: 873857-62-6 Current Sponsor code: OPT-80 Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Subject is aged at least 18 ? Confirmed diagnosis or history of IBD for at least 3 months ? CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrolment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: • Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrolment. • Presence of an ostomy or short bowel syndrome • Subject has a current diagnosis of toxic megacolon • Subject has previously participated in a CDI vaccine study • Subject has hypersensitivity to fidaxomicin or any of its components

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection on Day 1, Day 5 and Day 10 of treatment. ;Secondary Objective: The secondary objectives are to: ? compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. diff total viable count and spore count during fidaxomicin treatment and if achieved, the time to microbial eradication ? determine time to negative CDI toxin assay in stool specimens during fidaxomicin treatment ? compare differences in fidaxomicin stool concentrations and metabolite OP-1118 throughout therapy from Day 1, Day 5 and Day 10 ? assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving fidaxomicin throughout the study until Visit 8 (Day 180, EOS) ? record the incidence and severity of AEs up to EOS Visit 8 (Day 180) ? document impact of treatment on Quality of Life as measured by the changes in Short IBDQ score from Baseline Visit 1 to Visit 3 (Day 10), Visit 5 (Day 26), Visit 6 (Day 40) and Visit 7 (Day 90), EOS Visit 8 (Day 180) and to any confirmed recurrence episode ;Primary end point(s): Primary endpoints are the pharmacokinetic parameters derived for plasma concentrations of both fidaxomicin and OP-1118.;Timepoint(s) of evaluation of this end point: Day 1, 5 and 10	—

Measure

Time frame

Main Objective: The primary objective of the study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection on Day 1, Day 5 and Day 10 of treatment. ;Secondary Objective: The secondary objectives are to: ? compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. diff total viable count and spore count during fidaxomicin treatment and if achieved, the time to microbial eradication ? determine time to negative CDI toxin assay in stool specimens during fidaxomicin treatment ? compare differences in fidaxomicin stool concentrations and metabolite OP-1118 throughout therapy from Day 1, Day 5 and Day 10 ? assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving fidaxomicin throughout the study until Visit 8 (Day 180, EOS) ? record the incidence and severity of AEs up to EOS Visit 8 (Day 180) ? document impact of treatment on Quality of Life as measured by the changes in Short IBDQ score from Baseline Visit 1 to Visit 3 (Day 10), Visit 5 (Day 26), Visit 6 (Day 40) and Visit 7 (Day 90), EOS Visit 8 (Day 180) and to any confirmed recurrence episode ;Primary end point(s): Primary endpoints are the pharmacokinetic parameters derived for plasma concentrations of both fidaxomicin and OP-1118.;Timepoint(s) of evaluation of this end point: Day 1, 5 and 10

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Secondary

Measure	Time frame
Secondary end point(s): ? CDI clinical response at Day 12 (TOC) ? microbiological response in terms of C. difficile total viable count, spore count and negative CDI toxin assay ? stool concentrations of fidaxomicin and its metabolite OP-1118 ? length of hospital stay, readmissions and resource utilization ? incidence and severity of AEs ? Short IBDQ score ;Timepoint(s) of evaluation of this end point: Day 1, 5, 10, 12, 26, 40, 90 and 180 (depending on endpoint)	—

Measure

Time frame

Secondary end point(s): ? CDI clinical response at Day 12 (TOC) ? microbiological response in terms of C. difficile total viable count, spore count and negative CDI toxin assay ? stool concentrations of fidaxomicin and its metabolite OP-1118 ? length of hospital stay, readmissions and resource utilization ? incidence and severity of AEs ? Short IBDQ score ;Timepoint(s) of evaluation of this end point: Day 1, 5, 10, 12, 26, 40, 90 and 180 (depending on endpoint)

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Countries

Austria, Czech Republic, France, Germany, Greece, Italy, Poland, Russian Federation, United Kingdom

Contacts

Public ContactAndreas Karas

Astellas Pharma Europe Ltd.

andreas.karas@astellas.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026