Phase 3 Study With Cadazolid in CDAD

Condition(s) targeted: Clostridium Difficile Associated Diarrhea

Intervention: Cadazolid (Drug); vancomycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Paul McGovern, MD, Study Director, Affiliation: Actelion

Overall contact:
global medical Information, Email: medinfo@actelion.com

Subjects with CDAD are randomized and then treated with study drug for 10 days. At the end of treatment, cure is assessed; subjects are then followed-up to assess any disease recurrence.

Official title: AC-061A301, 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical Cure at End of Treatment

Secondary outcome:

Sustained Cure

Time to Resolution of Diarrhea

CDAD Symptoms

Detailed description: An interventional study to investigate the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. 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.

global medical Information, Email: medinfo@actelion.com

Investigator Site, Footscray 3011, Australia; Recruiting
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Investigator Site, Geelong 3220, Australia; Recruiting
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Investigator Site, Melbourne 3168, Australia; Recruiting
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Investigator Site, Parkville 3052, Australia; Recruiting
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Investigator Site, Southport 4215, Australia; Recruiting
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Investigator Site, Porto Alegre, Brazil; Recruiting
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Investigator Site, Sao Paulo 04231-030, Brazil; Recruiting
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Investigator Site, Sao Paulo, Brazil; Recruiting
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Investigator Site, Calgary T2N 2T9, Canada; Recruiting
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Investigator Site, Edmonton T6G 2X8, Canada; Recruiting
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Investigator Site, Hamilton, Canada; Recruiting
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Investigator Site, Montreal H1T 2M4, Canada; Recruiting
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Investigator Site, Saint-Jermone J7Z 5T3, Canada; Recruiting
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Investigator Site, Caen 14033, France; Recruiting
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Investigator Site, Dijon 77908, France; Recruiting
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Investigator Site, France 75013, France; Recruiting
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Investigator Site, Grenoble 38043, France; Recruiting
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Investigator Site, Lille 59037, France; Recruiting
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Investigator Site, Orleans 86709, France; Recruiting
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Investigator Site, Paris 75679, France; Recruiting
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Investigator Site, Hamburg 20246, Germany; Recruiting
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Investigator Site, Jena 07747, Germany; Recruiting
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Investigator Site, Koln 50937, Germany; Recruiting
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Investigator Site, Laatzen 30880, Germany; Recruiting
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Invetigator Site, Magdeburg 39120, Germany; Recruiting
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Investigator Site, Marburg, Germany; Recruiting
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Investigator Site, Munchen 80336, Germany; Recruiting
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Investigator Site, Regensburg 93042, Germany; Recruiting
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Investigator Site, Bergamo 24127, Italy; Recruiting
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Investigator Site, Lecco 23900, Italy; Recruiting
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Investigator Site, Monza 20900, Italy; Recruiting
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Investigator Site, Roma 00149, Italy; Recruiting
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Investigator Site, Roma 00161, Italy; Recruiting
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Investigator Site, Apeldoorn 7334, Netherlands; Recruiting
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Investigator Site, Dordrecht, Netherlands; Recruiting
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Investigator Site, Ede 6717, Netherlands; Recruiting
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Investigator Site, Rotterdam 3083 AN, Netherlands; Recruiting
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Investigator Site, Zwolle, Netherlands; Recruiting
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Investigator Site, Callao 07011, Peru; Recruiting
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Investigator Site, Iquicota 16001, Peru; Recruiting
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Investigator Site, Iquitos 15003, Peru; Recruiting
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Investigator Site, Trujillo 13011, Peru; Recruiting
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Investigator Site, Bydgoszcz 85-030, Poland; Recruiting
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Investigator Site, Lodz 91-347, Poland; Recruiting
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Investigator Site, Myszowice 41-400, Poland; Recruiting
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Investigator Site, Poznan 61-285, Poland; Recruiting
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Investigator Site, Wroclaw 51-149, Poland; Recruiting
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Investigator Site, Bucharest 011461, Romania; Recruiting
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Investigator Site, Bucharest 080098, Romania; Recruiting
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Investigator Site, Constanta 900709, Romania; Recruiting
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Investigator Site, Craiova 200515, Romania; Recruiting
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Investigator Site, Badalona 08916, Spain; Recruiting
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Investigator Site, Barcelona 08025, Spain; Recruiting
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Investigator Site, Barcelona 08035, Spain; Recruiting
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Investigator Site, Barcelona 08036, Spain; Recruiting
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Investigator Site, Lerida 25198, Spain; Recruiting
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Investigator Site, Madrid 28007, Spain; Recruiting
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Investigator Site, Madrid 28660, Spain; Recruiting
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Investigator Site, Majadahonda 28222, Spain; Recruiting
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Investigator Site, Mobile, Alabama 36608, United States; Recruiting
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Investigator Site, Carmichael, California 95608, United States; Recruiting
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Investigator Site, Oceanside, California 92056, United States; Recruiting
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Investigator Site, Aurora, Colorado 80045, United States; Recruiting
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Investigator Site, Jacksonville, Florida 32209, United States; Recruiting
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Investigator Site, Naples, Florida 34110, United States; Recruiting
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Investigator Site, Orange Park, Florida 32073, United States; Recruiting
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Investigator Site, West Palm Beach, Florida 33401, United States; Recruiting
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Investigator Site, Augusta, Georgia 30912, United States; Recruiting
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Investigator Site, Decatur, Georgia 30033, United States; Recruiting
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Investigator Site, Idaho Falls, Idaho 83404, United States; Recruiting
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Investigator Site, North Chicago, Illinois 60064, United States; Recruiting
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Investigator Site, Carmel, Indiana 46032, United States; Recruiting
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Investigator Site, Lafayette, Indiana 47904, United States; Recruiting
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Investigator Site, Louisville, Kentucky 40202, United States; Recruiting
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Investigator Site, Baltimore, Maryland 21224, United States; Recruiting
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Investigator Site, Chevy Chase, Maryland 20815, United States; Recruiting
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Investigator Site, Boston, Massachusetts 02111, United States; Recruiting
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Investigator Site, South Weymouth, Massachusetts 02190, United States; Recruiting
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Investigator Site, Omaha, Nebraska 68114, United States; Recruiting
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Investigator Site, Newark, New Jersey 07103, United States; Recruiting
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Investigator Site, Brooklyn, New York 11229, United States; Recruiting
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Investigator Site, Flushing, New York 11355, United States; Recruiting
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Investigator Site, New York, New York 10016, United States; Recruiting
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Investigator Site, New York, New York 10032, United States; Recruiting
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Investigator Site, Syracuse, New York 13210, United States; Recruiting
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Investigator Site, Kinston, North Carolina 28501, United States; Recruiting
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Investigator Site, Fargo, North Dakota 58122, United States; Recruiting
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Investigator Site, Cincinnati, Ohio 45219, United States; Recruiting
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Investigator Site, Dayton, Ohio 46428, United States; Recruiting
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Investigator Site, Lima, Ohio 45801, United States; Recruiting
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Investigator Site, Toronto, Ontario M3N 1N1, Canada; Recruiting
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Investigator Site, Pittsburgh, Pennsylvania 15213, United States; Recruiting
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Investigator Site, West Reading, Pennsylvania 19611, United States; Recruiting
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Investigator Site, Providence, Rhode Island 02906, United States; Recruiting
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Investigator Site, Columbia, South Carolina 29203, United States; Recruiting
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Investigator Site, Chattanooga, Tennessee 37404, United States; Recruiting
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Investigator Site, Dallas, Texas 75216, United States; Recruiting
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Investigator Site, Houston, Texas 77030, United States; Recruiting
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Investigator Site, Winchester, Virginia 22601, United States; Recruiting
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Starting date: November 2013
Last updated: May 12, 2015