Status:

COMPLETED

Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

Lead Sponsor:

Actelion

Conditions:

Clostridium Difficile Infection

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to eval...

Eligibility Criteria

Inclusion

  • Key
  • Male or female
  • At least 18 years of age
  • With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.
  • Key

Exclusion

  • Concurrent life threatening condition.
  • Immuno-compromised subjects, concomittant immuno-suppresive treatment.
  • Concomitant antimicrobial treatment for CDAD.
  • Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol

Key Trial Info

Start Date :

January 25 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 12 2012

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT01222702

Start Date

January 25 2011

End Date

November 12 2012

Last Update

June 14 2017

Active Locations (23)

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Page 1 of 6 (23 locations)

1

Clinical Investigative Site 6902

Newark, Delaware, United States, 19718

2

Clinical Investigative Site 6919

Jacksonville, Florida, United States, 32207

3

Clinical Investigative Site 6938

Orlando, Florida, United States, 32837

4

Clinical Investigative Site 6930

Decatur, Georgia, United States, 30033