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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

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02254967

Astellas Study ID

The unique identification code given by the study sponsor.

2819-MA-1002

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2013-004619-31

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Condition

Infections

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

60 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

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

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

Would you like more information about clinical trial sites that are recruiting participants for 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? Contact us by filling our your information to the right and we’ll respond to you.

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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

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