Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

NCT01222702 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AC-061A201
• Study Type: interventional
• Target: 84
• Locations: 6 countries
• Sites: 23

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.

Conditions

Clostridium Difficile Infection

Keywords

CDIFF; CDAD; CDI; Clostridium difficile infection

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate at test-of-cure

  Percentages of subjects with clinical cure are calculated, with clinical cure being defined as resolution of diarrhea with no further Clostridium Difficile-associated diarrhea (CDAD) treatment required at test-of-cure (TOC) visit. Resolution of diarrhea was defined as the occurrence of ≤ 2 semi-formed or formed stools during 24 h for at least 2 consecutive 24 h periods.

  Day 13 or 24-72 hours after end of treatment

Secondary Outcomes (5)

• Recurrence rate

  Between Day 13 and Day 41 (within 4 weeks after end of treatment)

• Sustained cure rate

  Between Day 13 and day 41 (within 4 weeks after end of treatment)

• Time to resolution of diarrhea

  From Day 1 up to Day 13 (or 24-72 hours after end of treatment)

• Incidence of treatment-emergent adverse events

  From Day 1 to Day 14

• Adverse events leading to premature discontinuation of study treatment

  Up to Day 10

Other Outcomes (1)

• Modified clinical cure rate

  Day 13 or 24-72 hours after end of treatment

Study Arms (4)

Cadazolid 250 mg

EXPERIMENTAL

Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days

Drug: Cadazolid; Drug: Placebo-matching vancomycin

Cadazolid 500 mg

EXPERIMENTAL

Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days

Drug: Cadazolid; Drug: Placebo-matching vancomycin

Cadazolid 1000 mg

EXPERIMENTAL

Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days

Drug: Cadazolid; Drug: Placebo-matching vancomycin

Vancomycin 125 mg

ACTIVE COMPARATOR

Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days

Drug: Vancomycin; Drug: Placebo-matching cadazolid

Interventions

Cadazolid DRUG

Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration

Also known as: ACT-179811

Cadazolid 1000 mg; Cadazolid 250 mg; Cadazolid 500 mg

Vancomycin DRUG

Vancomycin, provided as capsules (125 mg) for oral administration

Also known as: Vancomycin hydrochloride

Vancomycin 125 mg

Placebo-matching cadazolid DRUG

Placebo of cadazolid powder for oral suspension

Vancomycin 125 mg

Placebo-matching vancomycin DRUG

Placebo of vancomycin capsules

Cadazolid 1000 mg; Cadazolid 250 mg; Cadazolid 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• At least 18 years of age
• With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (23)

Clinical Investigative Site 6902

Newark, Delaware, 19718, United States

Location

Clinical Investigative Site 6919

Jacksonville, Florida, 32207, United States

Location

Clinical Investigative Site 6938

Orlando, Florida, 32837, United States

Location

Clinical Investigative Site 6930

Decatur, Georgia, 30033, United States

Location

Clinical Investigative Site 6935

Marietta, Georgia, 30060, United States

Location

Clinical Investigative Site 6915

Idaho Falls, Idaho, 83404, United States

Location

Clinical Investigative Site 6906

Chicago, Illinois, 60637, United States

Location

Clinical Investigative Site 6917

Boston, Massachusetts, 02111, United States

Location

Clinical Investigative Site 6936

Royal Oak, Michigan, 48073, United States

Location

Clinical Investigative Site 6903

Columbus, Ohio, 43215, United States

Location

Clinical Investigative Site 6914

Houston, Texas, 77030, United States

Location

Clinical Investigative Site 6605

Victoria, British Columbia, V8R 1J8, Canada

Location

Clinical Investigative Site 6601

Montreal, Quebec, H3T 1E2, Canada

Location

Clinical Investigative Site 6606

Sherbrooke, Quebec, J1H5N4, Canada

Location

Clinical Ivestigative Site 6602

Calgary, T2N2T8, Canada

Location

Clinical Investigative Site 6632

Cologne, 50937, Germany

Location

Clinical Investigative Site 6633

Regensburg, 93042, Germany

Location

Clinical Investigative Site 6634

Ulm, 89081, Germany

Location

Clinical Investigative Site 6734

Busto Arsizio, 21052, Italy

Location

Clinical Investigative Site 6735

Modena, 4114, Italy

Location

Clinical Investigative Site 6702

Örebro, 70185, Sweden

Location

Clinical Investigative Site 6801

Blackpool, FY3 8NR, United Kingdom

Location

Clinical Investigative Site 6804

York, YO31 8HE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 26248357 RESULT

• 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.

  PMID: 26433782 RESULT

MeSH Terms

Conditions

Clostridium Infections

Interventions

cadazolid; Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pascal Charef, DVM

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 18, 2010
• Study Start: January 25, 2011
• Primary Completion: October 16, 2012
• Study Completion: November 12, 2012
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

CA (4); SE (1); DE (3); US (11); IT (2); GB (2)