A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
EXTEND
A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population
2 other identifiers
interventional
364
22 countries
109
Brief Summary
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2014
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedStudy Start
First participant enrolled
November 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2016
CompletedOctober 31, 2024
October 1, 2024
1.4 years
September 25, 2014
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Secondary Outcomes (8)
Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
Day 40, 55, 90
Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
Day 12, 27
Percentage of Participants with a Clinical Response of CDI at Day 12
Day 12
Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
Baseline through day 90
Time to Resolution of Diarrhea (TTROD)
Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
- +3 more secondary outcomes
Study Arms (2)
Fidaxomicin Extended Pulsed Regimen (EPFX)
EXPERIMENTALParticipants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.
Vancomycin
EXPERIMENTALParticipants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.
Interventions
oral tablets administered in an extended pulsed regimen
Eligibility Criteria
You may qualify if:
- CDI is confirmed by clinical symptoms (either \> 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
- Subject agrees not to participate in another interventional study whilst participating in this study.
You may not qualify if:
- Subject is taking or requiring to be treated with prohibited medications
- Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
- Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
- Subject is unable to swallow oral study medication.
- Subject has a current diagnosis of toxic megacolon.
- Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
- Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
- Subject has previously participated in a CDI vaccine study
- Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Europe Ltd.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (109)
Site AT43002
Graz, 8020, Austria
Site AT43003
Linz, 4010, Austria
Site AT43001
Salzburg, 5020, Austria
Site BE32007
Aalst, 9300, Belgium
Site BE32006
Bruges, B-8000, Belgium
Site BE32001
Brussels, 1000, Belgium
Site BE32005
Brussels, B-1020, Belgium
Site BE32008
Liège, 4000, Belgium
Site HR38506
Osijek, 31000, Croatia
Site HR38503
Rijeka, 51000, Croatia
Site HR38505
Zadar, 23 000, Croatia
Site HR38501
Zagreb, 10000, Croatia
Site CZ42002
Brno-Bohunice, 62500, Czechia
Site CZ42005
Kyjov, 69733, Czechia
Site CZ42004
Opava, 74601, Czechia
Site CZ42003
Prague, 15006, Czechia
Site CZ42001
Praha 8 - Libeň, 18081, Czechia
Site DK45001
Herlev, 2730, Denmark
Site DK45005
Hillerød, 3400, Denmark
Site DK45004
Nykøbing Falster, 4800, Denmark
Site FI35801
Helsinki, 00029, Finland
Site FI35802
Turku, 20521, Finland
Site FR33003
Bordeaux, 33000, France
Site FR33008
Clermont-Ferrand, 63003, France
Site FR33006
Lille, 59037, France
Site FR33005
Nantes, 44000, France
Site FR33004
Nîmes, 30000, France
Site FR33001
Paris, 75010, France
Site FR33007
Paris, 75012, France
Site FR33002
Rennes, 35037, France
Site FR33009
Saint-Priest-en-Jarez, 42270, France
Site DE49001
Cologne, 50937, Germany
Site DE49011
Cologne, 51067, Germany
Site DE49012
Hamburg, 25599, Germany
Site DE49006
Leipzig, 04103, Germany
Site DE49016
Lübeck, 23538, Germany
Site DE49008
Marburg, 35043, Germany
Site GR30005
Athens, 10675, Greece
Site GR30008
Athens, 115 25, Greece
Site GR30001
Athens, 11527, Greece
Site GR30004
Athens, 11527, Greece
Site GR30009
Athens, 12461, Greece
Site GR30007
Athens, 14561, Greece
Site GR30002
Herakleion, Crete, 70013, Greece
Site GR30006
Larissa, 41221, Greece
Site GR30010
Thessaloniki, 546 36, Greece
Site HU36004
Békéscsaba, H-5600, Hungary
Site HU36010
Budapest, 1082, Hungary
Site HU36009
Budapest, 1088, Hungary
Site HU36001
Debrecen, H-4043, Hungary
Site HU36006
Gyula, H-5700, Hungary
Site HU36005
Mosonmagyaróvár, H-9200, Hungary
Site HU36008
Orosháza, H-5900, Hungary
Site HU36007
Pécs, H-7624, Hungary
Site IE35302
Dublin, 8, Ireland
Site IE35304
Limerick, V94 F858, Ireland
Site IT39009
Florence, 50134, Italy
Site IT39005
Genova, 16132, Italy
Site IT39004
Milan, 20122, Italy
Site IT39003
Monza, 20900, Italy
Site IT39007
Napoli, 80131, Italy
Site IT39002
Padua, 35128, Italy
Site IT39001
Pisa, 56124, Italy
Site IT39006
Roma, 00168, Italy
Site IT39010
Torino, 10154, Italy
Site PL48012
Lodz, PL, 91-347, Poland
Site PL48004
Gdynia, 81-348, Poland
Site PL48011
Szczecin, 71-899, Poland
Site PL48008
Warsaw, 02-507, Poland
Site PL48002
Warsaw, 02-781, Poland
Site PL48003
Zgierz, 95-100, Poland
Site PT35101
Almada, 2800-525, Portugal
Site PT35102
Amadora, 2720-276, Portugal
Site PT35106
Cotter, 4835-044, Portugal
Site PT35104
Vila Nova de Gaia, 4434-502, Portugal
Site PT35107
Vila Real, 5000-508, Portugal
Site RO40001
Bucharest, 21105, Romania
Site RO40003
Cluj-Napoca, 400348, Romania
Site RO40002
Lasi, 700116, Romania
Site RU70001
Moscow, 115478, Russia
Site RU70003
Moscow, 123423, Russia
Site SI38601
Ljubljana, 1000, Slovenia
Site SI38605
Ljubljana, 1000, Slovenia
Site SI38602
Maribor, 2000, Slovenia
Site SI38603
Murska Sobota, 9000, Slovenia
Site ES34003
Barakaldo, Vizcaya, 48903, Spain
Site ES34004
Barcelona, 08035, Spain
Site ES34005
Madrid, 28040, Spain
Site ES34006
Valencia, 46026, Spain
Site SE46002
Gothenburg, 41685, Sweden
Site SE46004
Jönköping, 55185, Sweden
Site SE46001
Lund, 22185, Sweden
Site SE46005
Uppsala, 75185, Sweden
Site CH41001
Lugano, Canton Ticino, CH-6903, Switzerland
Site CH41002
Sankt Gallen, 9007, Switzerland
Site CH41004
Zurich, 8006, Switzerland
Site TR90003
Adana, 01330, Turkey (Türkiye)
Site TR90002
Ankara, 06100, Turkey (Türkiye)
Site TR90007
Ankara, 06100, Turkey (Türkiye)
Site TR90001
Antalya, 07059, Turkey (Türkiye)
Site TR90006
Eskişehir, 26480, Turkey (Türkiye)
Site TR90005
Istanbul, 34662, Turkey (Türkiye)
Site TR90004
Istanbul, 34890, Turkey (Türkiye)
Site GB44003
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Site GB44006
Bristol, UK, BS2 8HW, United Kingdom
Site GB44008
Blackpool, FY3 8NR, United Kingdom
Site GB44005
Cardiff, CF14 4XW, United Kingdom
Site GB44010
London, E1 1BB, United Kingdom
Site GB44009
Truro, TR1 3LJ, United Kingdom
Related Publications (2)
Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.
PMID: 30911926DERIVEDGuery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.
PMID: 29273269DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2014
First Posted
October 2, 2014
Study Start
November 6, 2014
Primary Completion
March 27, 2016
Study Completion
May 5, 2016
Last Updated
October 31, 2024
Record last verified: 2024-10
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/.