Study Details
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
Clinicaltrials.gov ID
Astellas Study ID
2819-MA-1002
EudraCT ID
2013-004619-31
Condition
Infections
Phase
Phase 4
Age
60 years - N/A
Sex
Female & Male
Product
N/A
Type
Interventional
Trial Dates
Nov 2014 - May 2016
Masking
None (Open Label)
Enrollment number
364
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 summary
Study documents
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Locations
Site PL48006
Bydgoszcz, Poland, 80-094
Site DE49008
Marburg, Germany, 35043
Site GR30009
Athens, Greece, 12461
Site FI35801
Helsinki, Finland, 00029
Site PT35106
Cotter, Portugal, 4835-044
Site HU36008
Orosháza, Hungary, H-5900
Site HU36007
Pecs, Hungary, H-7624
Site IT39004
Milano, Italy, 20122
Site HR38506
Osijek, Croatia, 31000
Site DE49012
Hamburg, Germany, 25599
Site DK45004
Nykøbing Falster, Denmark, 4800
Site RO40003
Cluj-Napoca, Romania, 400348
Site GB44003
Sutton in Ashfield, United Kingdom, NG17 4JL
Site FR33008
Clermont- Ferrand Cedex 1, France, 63003
Site GR30006
Larisa, Greece, 41221
Site HU36006
Gyula, Hungary, H-5700
Site RO40001
Bucharest, Romania, 21105
Site DE49017
München, Germany, 80336
Site HU36005
Mosonmagyarovar, Hungary, H-9200
Site HU36009
Budapest, Hungary, 1088
Site CZ42001
Praha 8 - Libeň, Czech Republic, 18081
Site HU36010
Budapest, Hungary, 1082
Site DK45001
Herlev, Denmark, 2730
Site GR30008
Athens, Greece, 115 25
Site PL48010
Lodz, Poland, 90-153
Site BE32008
Liege, Belgium, 4000
Site DK45003
Aarhus N, Denmark, 8200
Site DE49001
Koeln, Germany, 50937
Site IT39009
Firenze, Italy, 50134
Site BE32005
Brussels, Belgium, B-1020
Site PL48002
Warsaw, Poland, 02-781
Site GB44010
London, United Kingdom, E1 1BB
Site PL48008
Warsaw, Poland, 02-507
Site TR90001
Antalya, Turkey, 07059
Site BE32007
Aalst, Belgium, 9300
Site FR33004
Nimes, France, 30000
Site BE32006
Brugge, Belgium, B-8000
Site GB44005
Cardiff, United Kingdom, CF14 4XW
Site FR33006
Lille Cedex, France, 59037
Site DE49009
Jena, Germany, 07747
Site FR33009
Saint-Priest en Jarez, France, 42270
Site RU70003
Moscow, Russian Federation, 123423
Site GB44011
Whythenshawe, United Kingdom, M23 9LT
Site IT39001
Pisa, Italy, 56124
Site DK45005
Hillerod, Denmark, 3400
Site FR33005
Nantes, France, 44000
Site SI38605
Ljubljana, Slovenia, 1000
Site FR33002
Rennes, France, 35037
Site GB44009
Truro, United Kingdom, TR1 3LJ
Site ES34005
Madrid, Spain, 28040
Site SE46002
Göteborg, Sweden, 41685
Site PL48012
Lodz, Poland, 91-347
Site IT39003
Monza, Italy, 20900
Site PT35101
Almada, Portugal, 2800-525
Site HR38501
Zagreb, Croatia, 10000
Site DE49007
Bonn, Germany, 53127
Site DE49016
Lübeck, Germany, 23538
Site TR90007
Ankara, Turkey, 06100
Site GR30004
Athens, Greece, 11527
Site AT43003
Linz, Austria, 4010
Site RU70002
Saint-Petersburg, Russian Federation, 197341
Site CH41002
St. Gallen, Switzerland, 9007
Site GR30002
Herakleion, Crete, Greece, 70013
Site ES34003
Barakaldo, Vizcaya, Spain, 48903
Site IT39005
Genova, Italy, 16132
Site PL48003
Zgierz, Poland, 95-100
Site RU70005
Smolensk, Russian Federation, 214018
Site IT39007
Napoli, Italy, 80131
Site GB44012
Harrogate, United Kingdom, HG2 7SX
Site HU36004
Bekescsaba, Hungary, H-5600
Site RO40002
Lasi, Romania, 700116
Site ES34006
Valencia, Spain, 46026
Site AT43002
Graz, Austria, 8020
Site IT39010
Torino, Italy, 10154
Site GB44006
Bristol, United Kingdom, BS2 8HW
Site BE32001
Brussels, Belgium, 1000
Site PT35107
Vila Real, Portugal, 5000-508
Site IE35302
Dublin, Ireland, 8
Site NO47001
Fredrikstad, Norway, 1603
Site TR90005
Istanbul, Turkey, 34662
Site ES34004
Barcelona, Spain, 08035
Site TR90003
Adana, Turkey, 01330
Site DE49011
Köln, Germany, 51067
Site GR30005
Athens, Greece, 10675
Site RU70004
Samara, Russian Federation, 443079
Site GR30001
Athens, Greece, 11527
Site HR38505
Zadar, Croatia, 23 000
Site PT35104
Vila Nova de Gaia, Portugal, 4434-502
Site HU36001
Debrecen, Hungary, H-4043
Site IT39008
Palermo, Italy, 90127
Site CZ42005
Kyjov, Czech Republic, 69733
Site PL48004
Gdynia, Poland, 81-348
Site AT43001
Salzburg, Austria, 5020
Site FR33007
Paris, France, 75012
Site PL48011
Szczecin, Poland, 71-899
Site GR30010
Thessaloniki, Greece, 546 36
Site CZ42004
Opava, Czech Republic, 74601
Site CH41001
Lugano, Switzerland, CH-6903
Site SE46005
Uppsala, Sweden, 75185
Site CZ42002
Brno-Bohunice, Czech Republic, 62500
Site SI38603
Murska Sobota, Slovenia, 9000
Site FI35802
Turku, Finland, 20521
Site SE46001
Lund, Sweden, 22185
Site GB44004
Great Yarmouth, United Kingdom, NR31 6LA
Site SE46004
Jönköping, Sweden, 55185
Site IT39002
Padova, Italy, 35128
Site DE49006
Leipzig, Germany, 04103
Site IE35304
Limerick, Ireland, V94 F858
Site CZ42003
Praha 5, Czech Republic, 15006
Site FR33003
Bordeaux, France, 33000
Site TR90006
Eskisehir, Turkey, 26480
Site SE46006
Östersund, Sweden, 83183
Site TR90002
Ankara, Turkey, 06100
Site TR90004
Istanbul, Turkey, 34890
Site CH41004
Zürich, Switzerland, 8006
Site HR38502
Zagreb, Croatia, 10000
Site SI38602
Maribor, Slovenia, 2000
Site GB44008
Blackpool, United Kingdom, FY3 8NR
Site RU70001
Moscow, Russian Federation, 115478
Site PT35102
Amadora, Portugal, 2720-276
Site SI38601
Ljubljana, Slovenia, 1000
Site FR33001
Paris, France, 75010
Site IT39006
Roma, Italy, 00168
Site GR30007
Athens, Greece, 14561
Site HR38503
Rijeka, Croatia, 51000