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

PHASE4CompletedINTERVENTIONAL
Enrollment

364

Participants

Timeline

Start Date

November 6, 2014

Primary Completion Date

March 27, 2016

Study Completion Date

May 5, 2016

Conditions
Clostridium Difficile
Interventions
DRUG

Fidaxomicin

oral tablets administered in an extended pulsed regimen

DRUG

Vancomycin

oral capsule

Trial Locations (109)

8

Site IE35302, Dublin

1000

Site BE32001, Brussels

Site SI38601, Ljubljana

Site SI38605, Ljubljana

1082

Site HU36010, Budapest

1088

Site HU36009, Budapest

2000

Site SI38602, Maribor

2730

Site DK45001, Herlev

3400

Site DK45005, Hillerød

4000

Site BE32008, Liège

4010

Site AT43003, Linz

4800

Site DK45004, Nykøbing Falster

5020

Site AT43001, Salzburg

8006

Site CH41004, Zurich

8020

Site AT43002, Graz

9000

Site SI38603, Murska Sobota

9007

Site CH41002, Sankt Gallen

9300

Site BE32007, Aalst

10000

Site HR38501, Zagreb

10154

Site IT39010, Torino

10675

Site GR30005, Athens

11527

Site GR30001, Athens

Site GR30004, Athens

12461

Site GR30009, Athens

14561

Site GR30007, Athens

15006

Site CZ42003, Prague

16132

Site IT39005, Genova

18081

Site CZ42001, Praha 8 - Libeň

20122

Site IT39004, Milan

20521

Site FI35802, Turku

20900

Site IT39003, Monza

21105

Site RO40001, Bucharest

22185

Site SE46001, Lund

23538

Site DE49016, Lübeck

25599

Site DE49012, Hamburg

26480

Site TR90006, Eskişehir

28040

Site ES34005, Madrid

30000

Site FR33004, Nîmes

31000

Site HR38506, Osijek

33000

Site FR33003, Bordeaux

34662

Site TR90005, Istanbul

34890

Site TR90004, Istanbul

35037

Site FR33002, Rennes

35043

Site DE49008, Marburg

35128

Site IT39002, Padua

41221

Site GR30006, Larissa

41685

Site SE46002, Gothenburg

42270

Site FR33009, Saint-Priest-en-Jarez

44000

Site FR33005, Nantes

46026

Site ES34006, Valencia

48903

Site ES34003, Barakaldo, Vizcaya

50134

Site IT39009, Florence

50937

Site DE49001, Cologne

51000

Site HR38503, Rijeka

51067

Site DE49011, Cologne

55185

Site SE46004, Jönköping

56124

Site IT39001, Pisa

59037

Site FR33006, Lille

62500

Site CZ42002, Brno-Bohunice

63003

Site FR33008, Clermont-Ferrand

69733

Site CZ42005, Kyjov

70013

Site GR30002, Herakleion, Crete

74601

Site CZ42004, Opava

75010

Site FR33001, Paris

75012

Site FR33007, Paris

75185

Site SE46005, Uppsala

80131

Site IT39007, Napoli

115478

Site RU70001, Moscow

123423

Site RU70003, Moscow

400348

Site RO40003, Cluj-Napoca

700116

Site RO40002, Lasi

B-8000

Site BE32006, Bruges

B-1020

Site BE32005, Brussels

23 000

Site HR38505, Zadar

00029

Site FI35801, Helsinki

04103

Site DE49006, Leipzig

115 25

Site GR30008, Athens

546 36

Site GR30010, Thessaloniki

H-5600

Site HU36004, Békéscsaba

H-4043

Site HU36001, Debrecen

H-5700

Site HU36006, Gyula

H-9200

Site HU36005, Mosonmagyaróvár

H-5900

Site HU36008, Orosháza

H-7624

Site HU36007, Pécs

V94 F858

Site IE35304, Limerick

00168

Site IT39006, Roma

91-347

Site PL48012, Lodz

81-348

Site PL48004, Gdynia

71-899

Site PL48011, Szczecin

02-507

Site PL48008, Warsaw

02-781

Site PL48002, Warsaw

95-100

Site PL48003, Zgierz

2800-525

Site PT35101, Almada

2720-276

Site PT35102, Amadora

4835-044

Site PT35106, Cotter

4434-502

Site PT35104, Vila Nova de Gaia

5000-508

Site PT35107, Vila Real

08035

Site ES34004, Barcelona

CH-6903

Site CH41001, Lugano

01330

Site TR90003, Adana

06100

Site TR90002, Ankara

Site TR90007, Ankara

07059

Site TR90001, Antalya

NG17 4JL

Site GB44003, Sutton in Ashfield

BS2 8HW

Site GB44006, Bristol

FY3 8NR

Site GB44008, Blackpool

CF14 4XW

Site GB44005, Cardiff

E1 1BB

Site GB44010, London

TR1 3LJ

Site GB44009, Truro

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Astellas Pharma Europe Ltd.

INDUSTRY

NCT02254967 - 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 | Biotech Hunter | Biotech Hunter