Phase 3 Study With Cadazolid in CDAD (AC061A302)

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-061A302, 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, Buenos Aires 1657, Argentina; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Cordoba 5000, Argentina; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Cordoba x5000jrd, Argentina; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, La Plata 1900, Argentina; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Bruxelles 1000, Belgium; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Gent 9000, Belgium; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Leuven 3000, Belgium; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Belo Horizonte 30150, Brazil; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Porto Alegre 90160-093, Brazil; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Rio De Janeiro 21941, Brazil; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, New Brunswick E2L 4L2, Canada; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Trois-Rivieres G8Z 3R9, Canada; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Winnipeg R3A iRp, Canada; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Santiago 8431657, Chile; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Santiago 7560171, Chile; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Santiago 7500551, Chile; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Opava 746 01, Czech Republic; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Ostrava 708 52, Czech Republic; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Praha 140 21, Czech Republic; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Praha 150 06, Czech Republic; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Alexandroupolis 68100, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Athens 10676, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Athens 11526, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Athens 11527, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Athens 12462, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Herakleion 71110, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Piraeus 18536, Greece; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Budapest 1088, Hungary; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Budapest 1097, Hungary; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Debrecen 4043, Hungary; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Szekszard 7100, Hungary; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Afula 1834111, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Hadera 38100, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Haifa 31096, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Holon 58100, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Jerusalem 91120, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Kfar Saba 44281, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Petach Tikva 49100, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Ramat-Gan 52621, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Safed 13100, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Tel Aviv 64239, Israel; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Daegu 700-721, Korea, Republic of; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Incheon 405-760, Korea, Republic of; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Seoul 120-752, Korea, Republic of; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Seoul 158-710, Korea, Republic of; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Seoul 138-736, Korea, Republic of; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Seoul 136-705, Korea, Republic of; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Invetigator Site, Cidra 00739, Puerto Rico; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Bratislava 833 05, Slovakia; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Nitra 950 01, Slovakia; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Bradford BD9 6RJ, United Kingdom; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Leeds LS9 7FT, United Kingdom; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Manchester M13 9WL, United Kingdom; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Salford M6 8HD, United Kingdom; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Birmingham, Alabama 35249, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, La Jolla, California 92093, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Mission Hills, California 91345, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Miami, Florida 33173, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, New Port Richey, Florida 34652, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Pensacola, Florida 32504, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Port St. Lucie, Florida 34987, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Marietta, Georgia 30060, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Chicago, Illinois 60637, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Hines, Illinois 60141, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Bowling Green, Kentucky 42101, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Shreveport, Louisiana 71103, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Lewiston, Maine 04240, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Annapolis, Maryland 21401, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Framingham, Massachusetts 01702, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Springfield, Massachusetts 01199, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Detroit, Michigan 48201, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Detroit, Michigan 48202, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Troy, Michigan 48098, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Jackson, Mississippi 39202, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Butte, Montana 59701, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Omaha, Nebraska 68105, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Bronx, New York 10467, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Brooklyn, New York 11215, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Buffalo, New York 14215, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, New York, New York 10003, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Fayetteville, North Carolina 28304, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Jacksonville, North Carolina 28546, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Kinston, North Carolina 28501, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Cincinnati, Ohio 45219, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Mentor, Ohio 44060, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Toledo, Ohio 43608, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Toronto, Ontario M5G 2C4, Canada; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Monroeville, Pennsylvania 15146, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Chicoutimi, Quebec G7H 5H6, Canada; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Warwick, Rhode Island 02886, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Baytown, Texas 77521, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Dallas, Texas 75235, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Houston, Texas 77005, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Richmond, Virginia 23298, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Wenatchee, Washington 98801, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Investigator Site, Marshfield, Wisconsin 54449, United States; Recruiting
Global Medical Information, Email: medinfo@actelion.com

Starting date: November 2013
Last updated: May 12, 2015