Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
NCT ID: NCT01222702
Last Updated: 2017-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2011-01-25
2012-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cadazolid 250 mg
Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Placebo-matching vancomycin
Placebo of vancomycin capsules
Cadazolid 500 mg
Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Placebo-matching vancomycin
Placebo of vancomycin capsules
Cadazolid 1000 mg
Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Placebo-matching vancomycin
Placebo of vancomycin capsules
Vancomycin 125 mg
Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days
Vancomycin
Vancomycin, provided as capsules (125 mg) for oral administration
Placebo-matching cadazolid
Placebo of cadazolid powder for oral suspension
Interventions
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Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Vancomycin
Vancomycin, provided as capsules (125 mg) for oral administration
Placebo-matching cadazolid
Placebo of cadazolid powder for oral suspension
Placebo-matching vancomycin
Placebo of vancomycin capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Pascal Charef, DVM
Role: STUDY_DIRECTOR
Actelion
Locations
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Clinical Investigative Site 6902
Newark, Delaware, United States
Clinical Investigative Site 6919
Jacksonville, Florida, United States
Clinical Investigative Site 6938
Orlando, Florida, United States
Clinical Investigative Site 6930
Decatur, Georgia, United States
Clinical Investigative Site 6935
Marietta, Georgia, United States
Clinical Investigative Site 6915
Idaho Falls, Idaho, United States
Clinical Investigative Site 6906
Chicago, Illinois, United States
Clinical Investigative Site 6917
Boston, Massachusetts, United States
Clinical Investigative Site 6936
Royal Oak, Michigan, United States
Clinical Investigative Site 6903
Columbus, Ohio, United States
Clinical Investigative Site 6914
Houston, Texas, United States
Clinical Investigative Site 6605
Victoria, British Columbia, Canada
Clinical Investigative Site 6601
Montreal, Quebec, Canada
Clinical Investigative Site 6606
Sherbrooke, Quebec, Canada
Clinical Ivestigative Site 6602
Calgary, , Canada
Clinical Investigative Site 6632
Cologne, , Germany
Clinical Investigative Site 6633
Regensburg, , Germany
Clinical Investigative Site 6634
Ulm, , Germany
Clinical Investigative Site 6734
Busto Arsizio, , Italy
Clinical Investigative Site 6735
Modena, , Italy
Clinical Investigative Site 6702
Örebro, , Sweden
Clinical Investigative Site 6801
Blackpool, , United Kingdom
Clinical Investigative Site 6804
York, , United Kingdom
Countries
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References
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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.
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.
Other Identifiers
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AC-061A201
Identifier Type: -
Identifier Source: org_study_id
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