Study summary

The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.

Additional Study Details

Phase
3
Product
  • Fidaxomicin oral suspension
  • Fidaxomicin tablets
  • Vancomycin oral liquid
  • Vancomycin capsules
  • Type
    Interventional
    Masking
    Single (Investigator)
    Enrollment number
    148
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for A study to investigate the safety and efficacy of fidaxomicin (oral suspension or tablets) and vancomycin (oral liquid or capsules) in pediatric subjects with Clostridium difficile-associated Diarrhea (CDAD)? 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
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • 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 RO40006
      Iasi, Iasi, Romania
      Withdrawn
      Site PL48011
      Lodz, Poland, 91-738
      Completed
      Site BE32003
      Gent, Belgium, 9000
      Completed
      Site US10028
      Chapel Hill, NC, United States, 27599
      Withdrawn
      Site RO40004
      Bucharest, Romania
      Withdrawn
      Site US10002
      Los Angeles, CA, United States, 90095
      Withdrawn
      Site CA15002
      Montreal, Quebec, Canada, H4A 3J1
      Withdrawn
      Site PL48008
      Warsaw, Mazowieckie, Poland, 01-184
      Terminated
      Site US10027
      Cincinnati, OH, United States, 45229-3039
      Withdrawn
      Site IT39002
      Genova, Italy, 16147
      Completed
      Site BE32001
      Brussels, Flemish Brabant, Belgium, 1200
      Completed
      Site IT39001
      Roma, Italy, 165
      Completed
      Site US10037
      Salt Lake City, UT, United States, 84113
      Withdrawn
      Site RO40002
      Cluj Napoca, Cluj, Romania, 400217
      Completed
      Site IT39004
      Milano, Italy, 20122
      Completed
      Site DE49002
      Frankfurt am M., Germany, 60596
      Withdrawn
      Site US10021
      Milwaukee, WI, United States, 53226
      Completed
      Site US10015
      Orange, CA, United States, 92868
      Withdrawn
      Site US10031
      Jackson, MS, United States, 39216
      Withdrawn
      Site HU36003
      Budapest, Hungary, 1094
      Completed
      Site FR33002
      La Tronche, France, 38700
      Completed
      Site DE49001
      Muenster, Germany, 48149
      Completed
      Site PL48012
      Bialystok, Poland, 15 -274
      Withdrawn
      Site DE49007
      Berlin, Germany, 13353
      Completed
      Site DE49004
      Mainz, Germany, 55131
      Withdrawn
      Site US10012
      Lake Success, NY, United States, 11042
      Completed
      Site FR33001
      Nice, France, 06200
      Completed
      Site US10038
      Fort Worth, TX, United States, 76104
      Completed
      Site PL48004
      Debica, Poland, 39-200
      Completed
      Site RO40005
      Bucharest, Romania
      Completed
      Site US10030
      Omaha, NE, United States, 68114
      Withdrawn
      Site US10033
      Columbus, OH, United States, 43205
      Completed
      Site FR33007
      Nice, France, 06200
      Completed
      Site PL48006
      Tarnow, Poland, 33-100
      Withdrawn
      Site HU36007
      Debrecen, Hajdu-Bihar, Hungary, H-4031
      Completed
      Site ES34004
      Madrid, Madrid, Spain, 28046
      Completed
      Site PL48014
      Rzeszow, Poland, 35-210
      Completed
      Site US10034
      Johnson City, TN, United States, 37604
      Withdrawn
      Site US10009
      Baltimore, MD, United States, 21287
      Completed
      Site HU36006
      Budapest, Hungary, 1097
      Completed
      Site US10008
      Stony Brook, NY, United States, 11794-8111
      Completed
      Site US10022
      Memphis, TN, United States, 38105-2794
      Withdrawn
      Site US10018
      Boston, MA, United States, 02111
      Completed
      Site DE49006
      Freiburg, Germany, 79106
      Completed
      Site HU36004
      Szeged, Hungary, 6720
      Withdrawn
      Site US10029
      Ann Arbor, MI, United States, 48109-5364
      Withdrawn
      Site HU36001
      Budapest, Hungary, 1023
      Completed
      Site FR33005
      Paris, France, 75012
      Withdrawn
      Site US10003
      Cleveland, OH, United States, 44106-5048
      Withdrawn
      Site SK42102
      Banska Bystrica, Slovakia, 974 01
      Withdrawn
      Site RO40003
      Bucharest, Romania
      Completed
      Site US10010
      Chicago, IL, United States, 60637
      Completed
      Site CA15003
      Oshawa, ON, Canada, L1G 2B9
      Completed
      Site PL48002
      Warszawa, Mazowieckie, Poland, 04-730
      Withdrawn
      Site SK42101
      Martin, Slovakia, 036 59
      Completed
      Site DE49010
      Essen, Germany, 45122
      Completed
      Site US10025
      Louisville, KY, United States, 40202
      Completed
      Site PL48007
      Bydgoszcz, Poland, 85-030
      Completed
      Site ES34002
      Barcelona, Spain, 8950
      Completed
      Site FR33008
      Strasbourg cedex, France, 67098
      Withdrawn
      Site CA15001
      Halifax, NS, Canada, B3K 6R8
      Withdrawn
      Site PL48010
      Krakow, Malopolskie, Poland, 30-663
      Withdrawn
      Site US10026
      Miami, FL, United States, 33101
      Completed
      Site ES34003
      Valencia, Valencia, Spain, 46026
      Completed
      Site DE49003
      St. Augustin, Germany, 53757
      Withdrawn
      Site FR33003
      Montpellier cedex 5, France, 34295
      Withdrawn
      Site ES34006
      Madrid, Madrid, Spain, 28040
      Completed
      Site BE32002
      Liege, Belgium, 4020
      Withdrawn
      Site FR33006
      Marseille, France, 13005
      Withdrawn
      Site RO40001
      Timisoara, Timis, Romania, 300011
      Terminated
      Site US10014
      Toledo, OH, United States, 43606
      Completed
      Site ES34007
      Madrid, Madrid, Spain, 28009
      Withdrawn
      Site IT39005
      Napoli, Italy, 80131
      Completed
      Site US10032
      Kansas City, MO, United States, 64108
      Completed
      Site US10004
      Indianapolis, IN, United States, 46202

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