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)
SUNSHINE
A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
3 other identifiers
interventional
148
10 countries
44
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2015
Typical duration for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedStudy Start
First participant enrolled
January 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2018
CompletedResults Posted
Study results publicly available
December 7, 2018
CompletedNovember 26, 2024
November 1, 2024
3.2 years
August 11, 2014
October 23, 2018
November 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days
Initial clinical response (ICR) for ages from birth to \< 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to \< 18 years was defined as improvement in number and character of bowel movements as determined by \< 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to \< 2 years) or number of UBMs (for ages ≥ 2 years to \< 18 years).
Up to day 12
Secondary Outcomes (22)
Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days
Up to day 19
Percentage of Participants With Global Cure (GC) at EOT +9 Days
Up to day 19
Percentage of Participants With Recurrence of CDAD at EOT +9 Days
Up to day 19
Percentage of Participants With SCR at EOT +16 Days
Up to day 26
Percentage of Participants With GC at EOT +16 Days
Up to day 26
- +17 more secondary outcomes
Study Arms (2)
Fidaxomicin
EXPERIMENTALParticipants 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.
Vancomycin
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Subject is diagnosed with CDAD according to local diagnostic criteria. As a minimum there must be positive detection, within 72 hours prior to randomization, of either toxin A and/or toxin B in stool or positive detection of toxigenic C. difficile in stool and:
- 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.
You may not qualify if:
- Concurrent use of metronidazole, oral vancomycin or any other antibiotic treatments for CDAD. If the investigator feels the clinical imperative is to begin treatment before knowing the laboratory result for toxigenic C. difficile, up to four doses but no more than 24 hours of treatment with metronidazole, oral vancomycin or any other effective treatment for CDAD are allowed.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Europe B.V.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (44)
Site US10015
Orange, California, 92868, United States
Site US10010
Chicago, Illinois, 60637, United States
Site US10004
Indianapolis, Indiana, 46202, United States
Site US10025
Louisville, Kentucky, 40202, United States
Site US10032
Kansas City, Missouri, 64108, United States
Site US10030
Omaha, Nebraska, 68114, United States
Site US10008
Stony Brook, New York, 11794-8111, United States
Site US10028
Chapel Hill, North Carolina, 27599, United States
Site US10027
Cincinnati, Ohio, 45229-3039, United States
Site US10014
Toledo, Ohio, 43606, United States
Site US10034
Johnson City, Tennessee, 37604, United States
Site US10022
Memphis, Tennessee, 38105-2794, United States
Site US10038
Fort Worth, Texas, 76104, United States
Site US10037
Salt Lake City, Utah, 84113, United States
Site BE32001
Brussels, Flemish Brabant, 1200, Belgium
Site BE32003
Ghent, 9000, Belgium
Site BE32002
Liège, 4020, Belgium
Site CA15003
Oshawa, Ontario, L1G 2B9, Canada
Site FR33002
La Tronche, 38700, France
Site FR33001
Nice, 06200, France
Site FR33007
Nice, 06200, France
Site FR33005
Paris, 75012, France
Site FR33008
Strasbourg, 67098, France
Site DE49010
Essen, 45122, Germany
Site DE49002
Frankfurt Am M., 60596, Germany
Site DE49006
Freiburg im Breisgau, 79106, Germany
Site DE49004
Mainz, 55131, Germany
Site DE49001
Münster, 48149, Germany
Site DE49003
Saint Augustin, 53757, Germany
Site HU36006
Budapest, 1097, Hungary
Site HU36004
Szeged, 6720, Hungary
Site IT39004
Milan, 20122, Italy
Site IT39001
Roma, 165, Italy
Site PL48002
Warsaw, Masovian Voivodeship, 04-730, Poland
Site PL48012
Bialystok, 15 -274, Poland
Site PL48007
Bydgoszcz, 85-030, Poland
Site PL48004
Dębica, 39-200, Poland
Site PL48014
Rzeszów, 35-210, Poland
Site PL48006
Tarnów, 33-100, Poland
Site RO40005
Bucharest, Romania
Site ES34002
Barcelona, 8950, Spain
Site ES34007
Madrid, 28009, Spain
Site ES34004
Madrid, 28046, Spain
Site ES34003
Valencia, 46026, Spain
Related Publications (2)
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.
PMID: 31773143DERIVEDBorali 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.
PMID: 27182626DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Global Development, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Research Physician
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 18, 2014
Study Start
January 9, 2015
Primary Completion
March 7, 2018
Study Completion
March 7, 2018
Last Updated
November 26, 2024
Results First Posted
December 7, 2018
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.