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
N/A
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 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
  • 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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