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
  • 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 patient
    • A caregiver
    • A parent
    • A healthcare provider
    • 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
    • Indonesia
    • Ireland
    • Israel
    • Italy
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    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
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    • Mexico
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    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • 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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