Study summary

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).

This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

Additional Study Details

Phase
4
Product
N/A
Product
fidaxomicin
Type
Interventional
Masking
None (Open Label)
Enrollment number
25
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English

Get more information

Would you like more information about clinical trial sites that are recruiting participants for Study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
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  • Netherlands
  • New Zealand
  • Norway
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  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

    Contact Us
    Contact Us
    Withdrawn
    Site CZ42002
    Ostrava - Vitkovice, Czech Republic, 703 84
    Withdrawn
    Site PL48001
    Zgierz, Poland, 95-100
    Withdrawn
    Site GR30002
    Athens, Greece, 10675
    Withdrawn
    Site CZ42001
    Prague 7, Czech Republic, 170 00
    Withdrawn
    Site PL48004
    Lodz, PL, Poland, 91-347
    Completed
    Site GR30004
    Athens, Greece, 11527
    Completed
    Site PL48003
    Warsaw, Poland, 02-781
    Withdrawn
    Site GB44001
    Bournemouth, United Kingdom, BH7 7DW
    Completed
    Site IT39001
    Roma, Italy
    Completed
    Site PL48002
    Warszawa, Poland, 02-507
    Completed
    Site FR33002
    CLICHY, France, 92110
    Completed
    Site GB44002
    London, United Kingdom, E11 1NR
    Withdrawn
    Site GB44005
    Blackpool, United Kingdom, FY3 8NR
    Withdrawn
    Site DE49002
    Hamburg, Germany, 25599
    Completed
    Site RU70001
    Saint Petersburg, Russian Federation, 196247
    Withdrawn
    Site GB44003
    Nottingham, United Kingdom, NG7 2UH
    Completed
    Site RU70002
    Moscow, Russian Federation, 129110
    Withdrawn
    Site GR30003
    Thessaloniki, Greece, 546 42
    Completed
    Site IT39003
    Padova, Italy, 35128
    Completed
    Site RU70003
    Moscow, Russian Federation, 119435
    Completed
    Site FR33001
    PARIS, France, 75012
    Withdrawn
    Site AT43002
    Vienna, Austria, 1090
    Withdrawn
    Site AT43003
    Vienna, Austria, 1030
    Withdrawn
    Site AT43004
    Linz, Austria, 4020
    Withdrawn
    Site DE49001
    Jena, Germany, 07747
    Withdrawn
    Site GR30001
    Athens, Greece, 115 27
    Withdrawn
    Site IT39002
    Milano, Italy, 20157
    Completed
    Site AT43001
    Graz, Austria, 8036

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