Study Details

Back to Search Results

A study to investigate the safety and efficacy of fidaxomicin (oral suspension or tablets) and vancomycin (oral liquid or capsules) in pediatric subjects with Clostridium difficile-associated Diarrhea (CDAD)

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.
NCT02218372

Astellas Study ID

The unique identification code given by the study sponsor.

2819-CL-0202

EudraCT ID

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

2013-000508-40

Follow Trial

Condition

Infections

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

N/A - 17 years

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

Jan 2015 - Mar 2018

Masking

Single (Investigator)

Enrollment number

148

A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects with Clostridium difficile-associated Diarrhea

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 study to investigate the safety and efficacy of fidaxomicin (oral suspension or tablets) and vancomycin (oral liquid or capsules) in pediatric subjects with Clostridium difficile-associated Diarrhea (CDAD)? Contact us by filling our your information to the right and we’ll respond to you.

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

Locations

Site RO40006

Iasi, Romania

Site PL48011

Lodz, Poland, 91-738

Site BE32003

Gent, Belgium, 9000

Site US10028

Chapel Hill, United States, 27599

Site RO40004

Bucharest, Romania

Site US10002

Los Angeles, United States, 90095

Site CA15002

Montreal, Canada, H4A 3J1

Site PL48008

Warsaw, Poland, 01-184

Site US10027

Cincinnati, United States, 45229-3039

Site IT39002

Genova, Italy, 16147

Site BE32001

Brussels, Belgium, 1200

Site IT39001

Roma, Italy, 165

Site US10037

Salt Lake City, United States, 84113

Site RO40002

Cluj Napoca, Romania, 400217

Site IT39004

Milano, Italy, 20122

Site DE49002

Frankfurt am M., Germany, 60596

Site US10021

Milwaukee, United States, 53226

Site US10015

Orange, United States, 92868

Site US10031

Jackson, United States, 39216

Site HU36003

Budapest, Hungary, 1094

Site FR33002

La Tronche, France, 38700

Site DE49001

Muenster, Germany, 48149

Site PL48012

Bialystok, Poland, 15 -274

Site DE49007

Berlin, Germany, 13353

Site DE49004

Mainz, Germany, 55131

Site US10012

Lake Success, United States, 11042

Site FR33001

Nice, France, 06200

Site US10038

Fort Worth, United States, 76104

Site PL48004

Debica, Poland, 39-200

Site RO40005

Bucharest, Romania

Site US10030

Omaha, United States, 68114

Site US10033

Columbus, United States, 43205

Site FR33007

Nice, France, 06200

Site PL48006

Tarnow, Poland, 33-100

Site HU36007

Debrecen, Hungary, H-4031

Site ES34004

Madrid, Spain, 28046

Site PL48014

Rzeszow, Poland, 35-210

Site US10034

Johnson City, United States, 37604

Site US10009

Baltimore, United States, 21287

Site HU36006

Budapest, Hungary, 1097

Site US10008

Stony Brook, United States, 11794-8111

Site US10022

Memphis, United States, 38105-2794

Site US10018

Boston, United States, 02111

Site DE49006

Freiburg, Germany, 79106

Site HU36004

Szeged, Hungary, 6720

Site US10029

Ann Arbor, United States, 48109-5364

Site HU36001

Budapest, Hungary, 1023

Site FR33005

Paris, France, 75012

Site US10003

Cleveland, United States, 44106-5048

Site SK42102

Banska Bystrica, Slovakia, 974 01

Site RO40003

Bucharest, Romania

Site US10010

Chicago, United States, 60637

Site CA15003

Oshawa, Canada, L1G 2B9

Site PL48002

Warszawa, Poland, 04-730

Site SK42101

Martin, Slovakia, 036 59

Site DE49010

Essen, Germany, 45122

Site US10025

Louisville, United States, 40202

Site PL48007

Bydgoszcz, Poland, 85-030

Site ES34002

Barcelona, Spain, 8950

Site FR33008

Strasbourg cedex, France, 67098

Site CA15001

Halifax, Canada, B3K 6R8

Site PL48010

Krakow, Poland, 30-663

Site US10026

Miami, United States, 33101

Site ES34003

Valencia, Spain, 46026

Site DE49003

St. Augustin, Germany, 53757

Site FR33003

Montpellier cedex 5, France, 34295

Site ES34006

Madrid, Spain, 28040

Site BE32002

Liege, Belgium, 4020

Site FR33006

Marseille, France, 13005

Site RO40001

Timisoara, Romania, 300011

Site US10014

Toledo, United States, 43606

Site ES34007

Madrid, Spain, 28009

Site IT39005

Napoli, Italy, 80131

Site US10032

Kansas City, United States, 64108

Site US10004

Indianapolis, United States, 46202

The purpose of this website is to offer education and information to patients and their families and friends, the public, and healthcare professionals about the clinical trial process. In addition, the website will provide specific information about Astellas clinical trials. Please read the complete Astellas Transparency Policy to learn about the clinical trial information available on this website

© ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.

POWERED BY:

Pharma Intelligence logo