Clinical trial NCT01222702: Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Official title: A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile Infection
Keywords: CDIFF
CDAD
CDI
Clostridium difficile infection
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.


Eligibility criteria: Key Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Clinical cure rate at test-of-cure
timeFrame: Day 13 or 24-72 hours after end of treatment
Secondary outcomes:
measure: Recurrence rate
timeFrame: Between Day 13 and Day 41 (within 4 weeks after end of treatment)
measure: Sustained cure rate
timeFrame: Between Day 13 and day 41 (within 4 weeks after end of treatment)
measure: Time to resolution of diarrhea
timeFrame: From Day 1 up to Day 13 (or 24-72 hours after end of treatment)
measure: Incidence of treatment-emergent adverse events
timeFrame: From Day 1 to Day 14
measure: Adverse events leading to premature discontinuation of study treatment
timeFrame: Up to Day 10
Other outcomes:
measure: Modified clinical cure rate
timeFrame: Day 13 or 24-72 hours after end of treatment
Locations:
city: Newark
country: United States
facility: Clinical Investigative Site 6902
state: Delaware
city: Jacksonville
country: United States
facility: Clinical Investigative Site 6919
state: Florida
city: Orlando
country: United States
facility: Clinical Investigative Site 6938
state: Florida
city: Decatur
country: United States
facility: Clinical Investigative Site 6930
state: Georgia
city: Marietta
country: United States
facility: Clinical Investigative Site 6935
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Investigative Site 6915
state: Idaho
city: Chicago
country: United States
facility: Clinical Investigative Site 6906
state: Illinois
city: Boston
country: United States
facility: Clinical Investigative Site 6917
state: Massachusetts
city: Royal Oak
country: United States
facility: Clinical Investigative Site 6936
state: Michigan
city: Columbus
country: United States
facility: Clinical Investigative Site 6903
state: Ohio
city: Houston
country: United States
facility: Clinical Investigative Site 6914
state: Texas
city: Victoria
country: Canada
facility: Clinical Investigative Site 6605
state: British Columbia
city: Montreal
country: Canada
facility: Clinical Investigative Site 6601
state: Quebec
city: Sherbrooke
country: Canada
facility: Clinical Investigative Site 6606
state: Quebec
city: Calgary
country: Canada
facility: Clinical Ivestigative Site 6602
city: Koln
country: Germany
facility: Clinical Investigative Site 6632
city: Regensburg
country: Germany
facility: Clinical Investigative Site 6633
city: Ulm
country: Germany
facility: Clinical Investigative Site 6634
city: Busto Arsizio
country: Italy
facility: Clinical Investigative Site 6734
city: Modena
country: Italy
facility: Clinical Investigative Site 6735
city: Orebro
country: Sweden
facility: Clinical Investigative Site 6702
city: Blackpool
country: United Kingdom
facility: Clinical Investigative Site 6801
city: York
country: United Kingdom
facility: Clinical Investigative Site 6804
Study officials:
affiliation: Actelion
name: Pascal Charef, DVM
role: STUDY_DIRECTOR
References:
citation: Louie T, Nord CE, Talbot GH, Wilcox M, Gerding DN, Buitrago M, Kracker H, Charef P, Cornely OA. Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic Cadazolid in Patients with Clostridium difficile Infection. Antimicrob Agents Chemother. 2015 Oct;59(10):6266-73. doi: 10.1128/AAC.00504-15. Epub 2015 Jul 27.
citation: Gerding DN, Hecht DW, Louie T, Nord CE, Talbot GH, Cornely OA, Buitrago M, Best E, Sambol S, Osmolski JR, Kracker H, Locher HH, Charef P, Wilcox M. Susceptibility of Clostridium difficile isolates from a Phase 2 clinical trial of cadazolid and vancomycin in C. difficile infection. J Antimicrob Chemother. 2016 Jan;71(1):213-9. doi: 10.1093/jac/dkv300. Epub 2015 Oct 3.