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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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficile

Intervention: Fidaxomicin (Drug); Vancomycin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Europe Ltd.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Chair, Affiliation: Astellas Pharma Europe Ltd.

Overall contact:
Medical Affairs Europe, Phone: +44-203-379-8138, Email: Astellas.registration@astellas.com

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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sustained clinical cure of CDI at 30 days after end of treatment (EOT)

Secondary outcome:

Sustained clinical cure of CDI

Clinical response of CDI 2 days after EOT

Clinical response of CDI

Relapse as determined by whole genome sequencing of isolates

Time to Resolution of Diarrhea (TTROD) in hours

Recurrence of CDI

Time to recurrence

Disease-free survival

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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.

Locations and Contacts

Medical Affairs Europe, Phone: +44-203-379-8138, Email: Astellas.registration@astellas.com

Site: AT43001, Salzburg 5020, Austria; Recruiting

Site: BE32005, Brüssels B-1020, Belgium; Recruiting

Site: HR38506, Osijek 31000, Croatia; Recruiting

Site: HR38503, Rijeka 51000, Croatia; Recruiting

Site: HR38505, Zadar 23 000, Croatia; Recruiting

Site: HR38501, Zagreb 10000, Croatia; Recruiting

Site: CZ42002, Brno-Bohunice 62500, Czech Republic; Recruiting

Site: 42005, Kyjov 69733, Czech Republic; Recruiting

Site: CZ42004, Opava 74601, Czech Republic; Recruiting

Site: CZ42003, Praha 5 15006, Czech Republic; Recruiting

Site: CZ42001, Praha 8 18081, Czech Republic; Recruiting

Site: 45003, Aarhus N 8200, Denmark; Recruiting

Site: 45001, Herlev 2730, Denmark; Recruiting

Site: 45004, Nykøbing Falster 4800, Denmark; Recruiting

Site: 35801, Helsinki 00029, Finland; Recruiting

Site: 35802, Turku 20521, Finland; Recruiting

Site: FR33003, Bordeaux 33000, France; Recruiting

Site: FR33008, Clermont- Ferrand Cedex 1 63003, France; Recruiting

Site: FR33006, Lille Cedex 59037, France; Recruiting

Site: FR33005, Nantes 44000, France; Recruiting

Site: FR33004, Nimes 30000, France; Recruiting

Site: 33001, Paris 75010, France; Recruiting

Site: FR33007, Paris 75012, France; Recruiting

Site: FR33002, Rennes 35037, France; Recruiting

Site: FR33009, Saint-Priest en Jarez 42270, France; Recruiting

Site: DE49007, Bonn 53127, Germany; Recruiting

Site: DE49012, Hamburg 25599, Germany; Recruiting

Site: DE49009, Jena 07747, Germany; Recruiting

Site: DE49001, Koeln 50937, Germany; Recruiting

Site: DE49011, Koeln 51067, Germany; Recruiting

Site: DE49006, Leipzig 04103, Germany; Recruiting

Site: DE49016, Luebeck 23538, Germany; Recruiting

Site: DE49008, Marburg 35043, Germany; Recruiting

Site: DE49017, München 80336, Germany; Recruiting

Site: 30001, Athens 11527, Greece; Recruiting

Site: 30004, Athens 11527, Greece; Recruiting

Site: 30005, Athens 10675, Greece; Recruiting

Site: 30007, Athens 14561, Greece; Recruiting

Site: GR30008, Athens 115 25, Greece; Recruiting

Site: GR30009, Athens 12462, Greece; Recruiting

Site: 30006, Larisa 41221, Greece; Recruiting

Site: GR30010, Thessaloniki 546 36, Greece; Recruiting

Site: HU36001, Debrecen H-4043, Hungary; Recruiting

Site: HU36008, Oroshaza H-5960, Hungary; Recruiting

Site: HU36007, Pécs H-7624, Hungary; Recruiting

Site: 35304, Limerick, Ireland; Recruiting

Site: IT39009, Firenze 50134, Italy; Recruiting

Site: IT39005, Genova 16132, Italy; Recruiting

Site: IT39004, Milano 20122, Italy; Recruiting

Site: IT39003, Monza 20900, Italy; Recruiting

Site: IT39007, Napoli 80131, Italy; Recruiting

Site: IT39002, Padova 35128, Italy; Recruiting

Site: IT39008, Palermo 90127, Italy; Recruiting

Site: IT39001, Pisa 56124, Italy; Recruiting

Site: IT39006, Roma 00168, Italy; Recruiting

Site: IT39010, Torino 10154, Italy; Recruiting

Site: 47001, Fredrikstad 1603, Norway; Recruiting

Site: PL48006, Bydgoszcz 80-094, Poland; Recruiting

Site: PL48010, Lodz 90-153, Poland; Recruiting

Site: PL48008, Warsaw 02-507, Poland; Recruiting

Site: PL48003, Zgierz 95-100, Poland; Recruiting

Site: RO40001, Bucharest 21105, Romania; Recruiting

Site: RO40003, Cluj 400348, Romania; Recruiting

Site: RO40002, Iasi 700116, Romania; Recruiting

Site: RU70003, Moscow 123423, Russian Federation; Recruiting

Site: SI38601, Ljubljana 1000, Slovenia; Recruiting

Site: SI38605, Ljubljana 1000, Slovenia; Recruiting

Site: SI38602, Maribor 2000, Slovenia; Recruiting

Site: SI38603, Murska Sobota 9000, Slovenia; Recruiting

Site: 34003, Barakaldo, Vizcaya 48903, Spain; Recruiting

Site: 34004, Barcelona 08035, Spain; Recruiting

Site: 34005, Madrid 28040, Spain; Recruiting

Site: ES34006, Valencia 46026, Spain; Recruiting

Site: 46002, Göteborg 41685, Sweden; Recruiting

Site: 46004, Jönköping 55185, Sweden; Recruiting

Site: 46001, Lund 22185, Sweden; Recruiting

Site: 46005, Uppsala 75185, Sweden; Recruiting

Site: 46006, Östersund 83183, Sweden; Recruiting

Site: TR90003, Adana 01330, Turkey; Recruiting

Site: TR90002, Ankara 06100, Turkey; Recruiting

Site: TR90007, Ankara 06100, Turkey; Recruiting

Site: TR90001, Antalya 07059, Turkey; Recruiting

Site: TR90006, Eskisehir 26480, Turkey; Recruiting

Site: TR90004, Istanbul 34890, Turkey; Recruiting

Site: TR90005, Istanbul 34662, Turkey; Recruiting

Site: 44008, Blackpool FY3 8NR, United Kingdom; Recruiting

Site: GB44005, Cardiff CF14 4XW, United Kingdom; Recruiting

Site: 44004, Great Yarmouth NR31 6LA, United Kingdom; Recruiting

Site: 44012, Harrogate HG2 7SX, United Kingdom; Recruiting

Site: GB44010, London E1 1BB, United Kingdom; Recruiting

Site: 44009, Truro TR1 3LJ, United Kingdom; Recruiting

Site: GB44011, Wythenshawe M23 9LT, United Kingdom; Recruiting

Site: GR30002, Herakleion, Crete 71110, Greece; Recruiting

Site: 44003, Sutton-in-Ashfield, Nottinghamshire NG17 4JL, United Kingdom; Recruiting

Additional Information

Starting date: October 2014
Last updated: July 30, 2015

Page last updated: August 23, 2015

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