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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 (EXTEND)

Primary Purpose

Clostridium Difficile

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Fidaxomicin
Vancomycin
Sponsored by
Astellas Pharma Europe Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile focused on measuring Aged, Fidaxomicin, Clostridium Difficile, Vancomycin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site AT43002
  • Site AT43003
  • Site AT43001
  • Site BE32007
  • Site BE32006
  • Site BE32001
  • Site BE32005
  • Site BE32008
  • Site HR38506
  • Site HR38503
  • Site HR38505
  • Site HR38501
  • Site CZ42002
  • Site CZ42005
  • Site CZ42004
  • Site CZ42003
  • Site CZ42001
  • Site DK45001
  • Site DK45005
  • Site DK45004
  • Site FI35801
  • Site FI35802
  • Site FR33003
  • Site FR33008
  • Site FR33006
  • Site FR33005
  • Site FR33004
  • Site FR33001
  • Site FR33007
  • Site FR33002
  • Site FR33009
  • Site DE49012
  • Site DE49001
  • Site DE49011
  • Site DE49006
  • Site DE49016
  • Site DE49008
  • Site GR30005
  • Site GR30008
  • Site GR30001
  • Site GR30004
  • Site GR30009
  • Site GR30007
  • Site GR30002
  • Site GR30006
  • Site GR30010
  • Site HU36004
  • Site HU36010
  • Site HU36009
  • Site HU36001
  • Site HU36006
  • Site HU36005
  • Site HU36008
  • Site HU36007
  • Site IE35302
  • Site IE35304
  • Site IT39009
  • Site IT39005
  • Site IT39004
  • Site IT39003
  • Site IT39007
  • Site IT39002
  • Site IT39001
  • Site IT39006
  • Site IT39010
  • Site PL48012
  • Site PL48004
  • Site PL48011
  • Site PL48008
  • Site PL48002
  • Site PL48003
  • Site PT35101
  • Site PT35102
  • Site PT35106
  • Site PT35104
  • Site PT35107
  • Site RO40001
  • Site RO40003
  • Site RO40002
  • Site RU70001
  • Site RU70003
  • Site SI38601
  • Site SI38605
  • Site SI38602
  • Site SI38603
  • Site ES34003
  • Site ES34004
  • Site ES34005
  • Site ES34006
  • Site SE46002
  • Site SE46004
  • Site SE46001
  • Site SE46005
  • Site CH41001
  • Site CH41002
  • Site CH41004
  • Site TR90003
  • Site TR90002
  • Site TR90007
  • Site TR90001
  • Site TR90006
  • Site TR90005
  • Site TR90004
  • Site GB44003
  • Site GB44006
  • Site GB44008
  • Site GB44005
  • Site GB44010
  • Site GB44009

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fidaxomicin Extended Pulsed Regimen (EPFX)

Vancomycin

Arm Description

Participants 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.

Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
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 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.
Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., 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. Treatment response should be daily observed and evaluated after at least three days, assuming that the patient is not worsening on treatment) at TOC.
Percentage of Participants with a Clinical Response of CDI at Day 12
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., 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. Treatment response should be daily observed and evaluated after at least three days, assuming that the participant is not worsening on treatment) at TOC.
Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
For participants with a recurrence after TOC, whole genome sequencing of isolates is performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse is defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs).
Time to Resolution of Diarrhea (TTROD)
Time to resolution of diarrhea is defined as the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement [UBM] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, > 50% reduction in number of stools or > 75% reduction in volume of liquid stool) that are sustained through to TOC.
Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
For participants with clinical response at TOC, recurrence of CDI is defined as re-establishment of diarrhea after TOC to an extent (judged by the frequency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy.
Time to Recurrence of CDI after End of Active Treatment
Time to recurrence of CDI is defined as the time in days from clinical response until onset of recurrence of CDI for participants who respond at TOC.
Disease-free Survival After Day 10
Disease-free survival is defined as the time in days a participant does not have symptoms of diarrhea from day 10 up to day 90 for participants who respond at TOC.

Full Information

First Posted
September 25, 2014
Last Updated
November 9, 2018
Sponsor
Astellas Pharma Europe Ltd.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02254967
Brief Title
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
Acronym
EXTEND
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 6, 2014 (Actual)
Primary Completion Date
March 27, 2016 (Actual)
Study Completion Date
May 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe Ltd.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile
Keywords
Aged, Fidaxomicin, Clostridium Difficile, Vancomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fidaxomicin Extended Pulsed Regimen (EPFX)
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.
Intervention Type
Drug
Intervention Name(s)
Fidaxomicin
Other Intervention Name(s)
OPT-80, ASP2819, Dificlir, Dificid
Intervention Description
oral tablets administered in an extended pulsed regimen
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Intervention Description
oral capsule
Primary Outcome Measure Information:
Title
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
Description
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.
Time Frame
Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Secondary Outcome Measure Information:
Title
Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
Description
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 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.
Time Frame
Day 40, 55, 90
Title
Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
Description
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., 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. Treatment response should be daily observed and evaluated after at least three days, assuming that the patient is not worsening on treatment) at TOC.
Time Frame
Day 12, 27
Title
Percentage of Participants with a Clinical Response of CDI at Day 12
Description
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., 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. Treatment response should be daily observed and evaluated after at least three days, assuming that the participant is not worsening on treatment) at TOC.
Time Frame
Day 12
Title
Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
Description
For participants with a recurrence after TOC, whole genome sequencing of isolates is performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse is defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs).
Time Frame
Baseline through day 90
Title
Time to Resolution of Diarrhea (TTROD)
Description
Time to resolution of diarrhea is defined as the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement [UBM] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, > 50% reduction in number of stools or > 75% reduction in volume of liquid stool) that are sustained through to TOC.
Time Frame
Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
Title
Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
Description
For participants with clinical response at TOC, recurrence of CDI is defined as re-establishment of diarrhea after TOC to an extent (judged by the frequency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy.
Time Frame
Day 40, 55, 90
Title
Time to Recurrence of CDI after End of Active Treatment
Description
Time to recurrence of CDI is defined as the time in days from clinical response until onset of recurrence of CDI for participants who respond at TOC.
Time Frame
From day 10 up to day 90
Title
Disease-free Survival After Day 10
Description
Disease-free survival is defined as the time in days a participant does not have symptoms of diarrhea from day 10 up to day 90 for participants who respond at TOC.
Time Frame
From day 10 up to day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Europe Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Site AT43002
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Site AT43003
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Site AT43001
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Site BE32007
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Site BE32006
City
Brugge
ZIP/Postal Code
B-8000
Country
Belgium
Facility Name
Site BE32001
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Site BE32005
City
Brussels
ZIP/Postal Code
B-1020
Country
Belgium
Facility Name
Site BE32008
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Site HR38506
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Site HR38503
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Site HR38505
City
Zadar
ZIP/Postal Code
23 000
Country
Croatia
Facility Name
Site HR38501
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Site CZ42002
City
Brno-Bohunice
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Site CZ42005
City
Kyjov
ZIP/Postal Code
69733
Country
Czechia
Facility Name
Site CZ42004
City
Opava
ZIP/Postal Code
74601
Country
Czechia
Facility Name
Site CZ42003
City
Praha 5
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Site CZ42001
City
Praha 8 - Libeň
ZIP/Postal Code
18081
Country
Czechia
Facility Name
Site DK45001
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Site DK45005
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Site DK45004
City
Nykøbing Falster
ZIP/Postal Code
4800
Country
Denmark
Facility Name
Site FI35801
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Site FI35802
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Site FR33003
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Site FR33008
City
Clermont- Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Site FR33006
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Site FR33005
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Site FR33004
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
Site FR33001
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Site FR33007
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Site FR33002
City
Rennes
ZIP/Postal Code
35037
Country
France
Facility Name
Site FR33009
City
Saint-Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Site DE49012
City
Hamburg
ZIP/Postal Code
25599
Country
Germany
Facility Name
Site DE49001
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Site DE49011
City
Köln
ZIP/Postal Code
51067
Country
Germany
Facility Name
Site DE49006
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Site DE49016
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Site DE49008
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Site GR30005
City
Athens
ZIP/Postal Code
10675
Country
Greece
Facility Name
Site GR30008
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Site GR30001
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Site GR30004
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Site GR30009
City
Athens
ZIP/Postal Code
12461
Country
Greece
Facility Name
Site GR30007
City
Athens
ZIP/Postal Code
14561
Country
Greece
Facility Name
Site GR30002
City
Herakleion, Crete
ZIP/Postal Code
70013
Country
Greece
Facility Name
Site GR30006
City
Larisa
ZIP/Postal Code
41221
Country
Greece
Facility Name
Site GR30010
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Site HU36004
City
Bekescsaba
ZIP/Postal Code
H-5600
Country
Hungary
Facility Name
Site HU36010
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Site HU36009
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Site HU36001
City
Debrecen
ZIP/Postal Code
H-4043
Country
Hungary
Facility Name
Site HU36006
City
Gyula
ZIP/Postal Code
H-5700
Country
Hungary
Facility Name
Site HU36005
City
Mosonmagyarovar
ZIP/Postal Code
H-9200
Country
Hungary
Facility Name
Site HU36008
City
Orosháza
ZIP/Postal Code
H-5900
Country
Hungary
Facility Name
Site HU36007
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Site IE35302
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Site IE35304
City
Limerick
ZIP/Postal Code
V94 F858
Country
Ireland
Facility Name
Site IT39009
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Site IT39005
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Site IT39004
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Site IT39003
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Site IT39007
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Site IT39002
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Site IT39001
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Site IT39006
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Site IT39010
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Site PL48012
City
Lodz
State/Province
PL
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Site PL48004
City
Gdynia
ZIP/Postal Code
81-348
Country
Poland
Facility Name
Site PL48011
City
Szczecin
ZIP/Postal Code
71-899
Country
Poland
Facility Name
Site PL48008
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Site PL48002
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Site PL48003
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
Site PT35101
City
Almada
ZIP/Postal Code
2800-525
Country
Portugal
Facility Name
Site PT35102
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Site PT35106
City
Cotter
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Site PT35104
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Site PT35107
City
Vila Real
ZIP/Postal Code
5000-508
Country
Portugal
Facility Name
Site RO40001
City
Bucharest
ZIP/Postal Code
21105
Country
Romania
Facility Name
Site RO40003
City
Cluj-Napoca
ZIP/Postal Code
400348
Country
Romania
Facility Name
Site RO40002
City
Lasi
ZIP/Postal Code
700116
Country
Romania
Facility Name
Site RU70001
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Site RU70003
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Site SI38601
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Site SI38605
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Site SI38602
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Site SI38603
City
Murska Sobota
ZIP/Postal Code
9000
Country
Slovenia
Facility Name
Site ES34003
City
Barakaldo, Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Site ES34004
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site ES34005
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Site ES34006
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Site SE46002
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
Facility Name
Site SE46004
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Site SE46001
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Site SE46005
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Site CH41001
City
Lugano
State/Province
Ticino
ZIP/Postal Code
CH-6903
Country
Switzerland
Facility Name
Site CH41002
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Site CH41004
City
Zürich
ZIP/Postal Code
8006
Country
Switzerland
Facility Name
Site TR90003
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Site TR90002
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Site TR90007
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Site TR90001
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Site TR90006
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Site TR90005
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Site TR90004
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Site GB44003
City
Sutton in Ashfield
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Site GB44006
City
Bristol
State/Province
UK
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Site GB44008
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Site GB44005
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Site GB44010
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Site GB44009
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
30911926
Citation
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.
Results Reference
derived
PubMed Identifier
29273269
Citation
Guery 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.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/patientStudySearch.aspx?RID=;;;2819-MA-1002
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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