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)
NCT ID: NCT02218372
Last Updated: 2024-11-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2015-01-09
2018-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fidaxomicin
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. Participants aged ≥ 6 years to \< 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
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
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. Participants aged ≥ 6 years to \< 18 years of age received a 125 mg vancomycin capsule 4 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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject from Birth to \< 2 years: watery diarrhea in the 24 hours prior to screening.
* Subject ≥ 2 years to \< 18 years: ≥ 3 unformed bowel movements in the 24 hours prior to screening.
* Male and female subjects aged from birth to \< 18 years: Note that in the United States of America subjects can only be included if aged ≥ 6 months to \< 18 years.
* For subjects \< 5 years: Negative rotavirus test.
* Female subject of childbearing potential:
* must have a negative urine pregnancy test at Screening, and
* must abstain from sexual activity for the duration of the study, or
* must use two forms of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.
* Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.
* Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.
Exclusion Criteria
* Subject has pseudomembranous colitis, fulminant colitis, toxic megacolon or ileus.
* Subject has a history of inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease etc.).
* Subject has diarrhea caused by an agent other than C. difficile (e.g. infections, infestations, drugs etc.).
* Subject has known hypersensitivity to fidaxomicin, vancomycin or their excipients or to teicoplanin.
* Subject has received an investigational therapy within 28 days, prior to Screening, with the exception of studies with primary treatment for cancer without novel Investigational Medicinal Product (IMP) and which do not affect the assessment of diarrhea.
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Research Physician
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site US10015
Orange, California, United States
Site US10010
Chicago, Illinois, United States
Site US10004
Indianapolis, Indiana, United States
Site US10025
Louisville, Kentucky, United States
Site US10032
Kansas City, Missouri, United States
Site US10030
Omaha, Nebraska, United States
Site US10008
Stony Brook, New York, United States
Site US10028
Chapel Hill, North Carolina, United States
Site US10027
Cincinnati, Ohio, United States
Site US10014
Toledo, Ohio, United States
Site US10034
Johnson City, Tennessee, United States
Site US10022
Memphis, Tennessee, United States
Site US10038
Fort Worth, Texas, United States
Site US10037
Salt Lake City, Utah, United States
Site BE32001
Brussels, Flemish Brabant, Belgium
Site BE32003
Ghent, , Belgium
Site BE32002
Liège, , Belgium
Site CA15003
Oshawa, Ontario, Canada
Site FR33002
La Tronche, , France
Site FR33001
Nice, , France
Site FR33007
Nice, , France
Site FR33005
Paris, , France
Site FR33008
Strasbourg, , France
Site DE49010
Essen, , Germany
Site DE49002
Frankfurt Am M., , Germany
Site DE49006
Freiburg im Breisgau, , Germany
Site DE49004
Mainz, , Germany
Site DE49001
Münster, , Germany
Site DE49003
Saint Augustin, , Germany
Site HU36006
Budapest, , Hungary
Site HU36004
Szeged, , Hungary
Site IT39004
Milan, , Italy
Site IT39001
Roma, , Italy
Site PL48002
Warsaw, Masovian Voivodeship, Poland
Site PL48012
Bialystok, , Poland
Site PL48007
Bydgoszcz, , Poland
Site PL48004
Dębica, , Poland
Site PL48014
Rzeszów, , Poland
Site PL48006
Tarnów, , Poland
Site RO40005
Bucharest, , Romania
Site ES34002
Barcelona, , Spain
Site ES34007
Madrid, , Spain
Site ES34004
Madrid, , Spain
Site ES34003
Valencia, , Spain
Countries
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References
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Wolf J, Kalocsai K, Fortuny C, Lazar S, Bosis S, Korczowski B, Petit A, Bradford D, Croos-Dabrera R, Incera E, Melis J, van Maanen R. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Clin Infect Dis. 2020 Dec 17;71(10):2581-2588. doi: 10.1093/cid/ciz1149.
Borali E, De Giacomo C. Clostridium Difficile Infection in Children: A Review. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e130-e140. doi: 10.1097/MPG.0000000000001264.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2013-000508-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SUNSHINE
Identifier Type: OTHER
Identifier Source: secondary_id
2819-CL-0202
Identifier Type: -
Identifier Source: org_study_id
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