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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01987895




Registration number
NCT01987895
Ethics application status
Date submitted
7/11/2013
Date registered
20/11/2013
Date last updated
4/05/2018

Titles & IDs
Public title
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
Scientific title
A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Secondary ID [1] 0 0
AC-061A301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clostridium Difficile Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cadazolid
Treatment: Drugs - Vancomycin
Treatment: Drugs - Cadazolid-matching placebo
Treatment: Drugs - Vancomycin-matching placebo

Experimental: Cadazolid - Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days

Active comparator: Vancomycin - Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days


Treatment: Drugs: Cadazolid
Cadazolid 250 mg as oral suspension twice daily.

Treatment: Drugs: Vancomycin
Vancomycin 125 mg as oral capsules 4 times daily.

Treatment: Drugs: Cadazolid-matching placebo
Placebo matching cadazolid and administered orally twice daily

Treatment: Drugs: Vancomycin-matching placebo
Placebo capsules matching vancomycin and administered orally 4 times per day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Timepoint [1] 0 0
Up to Day 12 on average (end-of-treatment + 2 days)
Primary outcome [2] 0 0
Clinical Cure Rate (CCR) in the Per-protocol Population
Timepoint [2] 0 0
Up to Day 12 on average (end-of-treatment + 2 days)
Secondary outcome [1] 0 0
Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population
Timepoint [1] 0 0
Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
Secondary outcome [2] 0 0
Kaplan-Meier Estimates for Resolution of Diarrhea
Timepoint [2] 0 0
Up to Day 10
Secondary outcome [3] 0 0
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
Timepoint [3] 0 0
Day 1 (baseline) and Day 3

Eligibility
Key inclusion criteria
* Signed Informed Consent.
* Male or female = 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
* Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* More than one previous episode of CDAD in the 3-month period prior to randomization.
* Evidence of life-threatening or fulminant CDAD.
* Likelihood of death within 72 hours from any cause.
* History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
* Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
* Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
* Unable or unwilling to comply with all protocol requirements.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2017
Sample size
Target
Accrual to date
Final
632
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigator Site - Geelong
Recruitment hospital [2] 0 0
Investigator Site - Southport
Recruitment postcode(s) [1] 0 0
3217 - Geelong
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Brazil
State/province [16] 0 0
Bahia
Country [17] 0 0
Brazil
State/province [17] 0 0
Porto Alegre
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Calgary
Country [21] 0 0
Canada
State/province [21] 0 0
Edmonton
Country [22] 0 0
Canada
State/province [22] 0 0
Hamilton
Country [23] 0 0
Canada
State/province [23] 0 0
Montreal
Country [24] 0 0
Canada
State/province [24] 0 0
Saint-Jerome
Country [25] 0 0
France
State/province [25] 0 0
Dijon
Country [26] 0 0
France
State/province [26] 0 0
Grenoble
Country [27] 0 0
France
State/province [27] 0 0
Lille
Country [28] 0 0
France
State/province [28] 0 0
Orleans
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Koln
Country [32] 0 0
Italy
State/province [32] 0 0
Bergamo
Country [33] 0 0
Italy
State/province [33] 0 0
Monza
Country [34] 0 0
Italy
State/province [34] 0 0
Roma
Country [35] 0 0
Netherlands
State/province [35] 0 0
Apeldoorn
Country [36] 0 0
Netherlands
State/province [36] 0 0
Dordrecht
Country [37] 0 0
Peru
State/province [37] 0 0
Lima
Country [38] 0 0
Poland
State/province [38] 0 0
Lancut
Country [39] 0 0
Poland
State/province [39] 0 0
Lodz
Country [40] 0 0
Poland
State/province [40] 0 0
Myslowice
Country [41] 0 0
Poland
State/province [41] 0 0
Wroclaw
Country [42] 0 0
Romania
State/province [42] 0 0
Bucharest
Country [43] 0 0
Romania
State/province [43] 0 0
Craiova
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Boadilla del Monte
Country [46] 0 0
Spain
State/province [46] 0 0
Lleida
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Majadahonda

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Claire Marrast, MD
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01987895