148
Participants
Start Date
January 9, 2015
Primary Completion Date
March 7, 2018
Study Completion Date
March 7, 2018
Fidaxomicin oral suspension
Participants from birth to \< 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.
Fidaxomicin tablets
Participants aged ≥ 6 years to \< 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
Vancomycin oral liquid
Participants from birth to \< 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.
Vancomycin capsules
Participants aged ≥ 6 years to \< 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
Site IT39001, Roma
Site HU36006, Budapest
Site BE32001, Brussels
Site BE32002, Liège
Site HU36004, Szeged
Site ES34002, Barcelona
Site BE32003, Ghent
Site IT39004, Milan
Site US10028, Chapel Hill
Site ES34007, Madrid
Site ES34004, Madrid
Site US10034, Johnson City
Site FR33002, La Tronche
Site US10025, Louisville
Site US10014, Toledo
Site DE49010, Essen
Site ES34003, Valencia
Site US10004, Indianapolis
Site DE49001, Münster
Site DE49003, Saint Augustin
Site DE49004, Mainz
Site DE49002, Frankfurt Am M.
Site US10010, Chicago
Site US10032, Kansas City
Site FR33008, Strasbourg
Site US10030, Omaha
Site FR33005, Paris
Site US10038, Fort Worth
Site DE49006, Freiburg im Breisgau
Site US10037, Salt Lake City
Site US10015, Orange
Site US10008, Stony Brook
Site US10027, Cincinnati
Site US10022, Memphis
Site CA15003, Oshawa
Site FR33001, Nice
Site FR33007, Nice
Site PL48002, Warsaw
Site PL48012, Bialystok
Site PL48007, Bydgoszcz
Site PL48004, Dębica
Site PL48014, Rzeszów
Site PL48006, Tarnów
Site RO40005, Bucharest
Merck Sharp & Dohme LLC
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY