Study Details

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A post-marketing, blinded study to investigate how effective fidaxomicin is compared to vancomycin in the sustained cure of Clostridium Difficile Infection in adults that are receiving therapy to suppress the immune system

Terminated/Withdrawn
The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01775397

Astellas Study ID

The unique identification code given by the study sponsor.

FID-EC-0001

EudraCT ID

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

2012-000531-88

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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

18 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 2012 - Apr 2013

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

12

A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

Study summary

Study documents

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

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Locations

LKH Graz, Univ.

Graz, Austria, 8036

Policlinico di Modena

Modena, Italy, 41100

Charité

Berlin, Germany, 10117

Instytut Hematologii i Transfu

Warszawa, Poland, 02-776

Laiko General Hospital

Athens, Greece, 11527

Swietokrzyskie Oncology Center

Kielce, Poland, 25-734

Centre of Heart Blood and Endo

Saint Petersburg, Russian Federation, 197341

Szpital Specjalistyczny w Brzo

Brzozów, Poland, 36-200

Institut Jules Bordet

Brussels, Belgium, 1000

General Hospital of Athens

Athens, Greece, 10675

St. Petersburg City Hospital #31

Saint Petersburg, Russian Federation, 197110

University Hospital of Crete

Heraklion, Greece, 70013

AKH Universitätsklinik

Vienna, Austria, 1090

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Medical University

Innsbruck, Austria, 6020

Univ. Klinik für Innere Medizi

Salzburg, Austria, 5020

HUCH

Helsinki, Finland, 00029

Institut Curie

Paris, France, 75005

Institut Gustave Roussy

Villejuif, France, 94805

MH Honvédkórház - I.Belgyógyás

Budapest, Hungary, 1134

Bristol Haematology and Oncology

Bristol, United Kingdom, BS2 8ED

R.M.Gorbacheva Inst of children

Saint Petersburg, Russian Federation, 197022

Szegedi Tudományegyetem Ált

Szeged, Hungary, 6720

Uppsala University Hospital

Uppsala, Sweden, 75185

Universitätsklinikum Halle

Halle, Germany, 6097

Universitätsklinikum

Essen, Germany, 45417

Karolinska University Hospital

Huddinge, Sweden, 14186

Metaxa Anticancer Hospital

Piraeus, Greece, 18537

Centro di Riferimento

Aviano, Italy, 33081

Hôpital Universitaire Erasme

Brussels, Belgium, 1070

Hopital Saint Louis

Paris, France, 75475

Main Military Clinical Hospital

Moscow, Russian Federation, 105229

H. U. Politecnico La Fe

Valencia, Spain, 46026

Klinik I für Innere Medizin

Koln, Germany, 50937

Hôpital Necker

Paris, France, 75743

Clinics of Samara State Medical

Samara, Russian Federation, 443079

Hematology Research Center

Moscow, Russian Federation, 125167

CHU de Liege

Liege, Belgium, 4000

H.U. Gregorio Maranon

Madrid, Spain, 28007

Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

Herlev University Hospital

Herlev, Denmark, 2730

Hospital 12 de Octubre

Madrid, Spain, 28041

Azienda Ospedaliera Pisana

Pisa, Italy, 56124

H. U. de Bellvitge

Barcelona, Spain, 08907

Imperial College School of Med

London, United Kingdom, W12 0HS

Diparitmento di Malattie

Genova, Italy, 16132

Semmelweis Egyetem Kútvölgyi

Budapest, Hungary, 1125

Turku Hospital

Turku, Finland, 20251

Szent István és Szent László

Budapest, Hungary, 1097

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