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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cadazolid
Vancomycin
Placebo-matching cadazolid
Placebo-matching vancomycin
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring CDIFF, CDAD, CDI, Clostridium difficile infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • 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

Sites / Locations

  • Clinical Investigative Site 6902
  • Clinical Investigative Site 6919
  • Clinical Investigative Site 6938
  • Clinical Investigative Site 6930
  • Clinical Investigative Site 6935
  • Clinical Investigative Site 6915
  • Clinical Investigative Site 6906
  • Clinical Investigative Site 6917
  • Clinical Investigative Site 6936
  • Clinical Investigative Site 6903
  • Clinical Investigative Site 6914
  • Clinical Investigative Site 6605
  • Clinical Investigative Site 6601
  • Clinical Investigative Site 6606
  • Clinical Ivestigative Site 6602
  • Clinical Investigative Site 6632
  • Clinical Investigative Site 6633
  • Clinical Investigative Site 6634
  • Clinical Investigative Site 6734
  • Clinical Investigative Site 6735
  • Clinical Investigative Site 6702
  • Clinical Investigative Site 6801
  • Clinical Investigative Site 6804

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Cadazolid 250 mg

Cadazolid 500 mg

Cadazolid 1000 mg

Vancomycin 125 mg

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Recurrence rate
Percentages of subjects with recurrence are calculated, with recurrence being defined as the occurrence of diarrhea (> 3 liquid or unformed stools within 24 h associated with positive C. difficile toxin A/B assay) within 4 weeks after EOT in subjects clinically cured (at test-of-cure).
Sustained cure rate
Percentages of subjects with sustained cure are calculated, with sustained cure being defined as clinical cure without CDAD recurrence up to the end of study
Time to resolution of diarrhea
Time to resolution of diarrhea was defined as the time (h) from the first intake of study treatment to the time (occurrence) of the first stool meeting the criteria for resolution of diarrhea up to test-of-cure.
Incidence of treatment-emergent adverse events
Percentage of subjects with any adverse events in each group from first study treatment intake up to 3 days after last study drug intake
Adverse events leading to premature discontinuation of study treatment
Number of patients in each group who discontinued the study treatment due to an adverse event

Full Information

First Posted
October 8, 2010
Last Updated
June 9, 2017
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01222702
Brief Title
Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Official Title
A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 25, 2011 (Actual)
Primary Completion Date
October 16, 2012 (Actual)
Study Completion Date
November 12, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
CDIFF, CDAD, CDI, Clostridium difficile infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cadazolid 250 mg
Arm Type
Experimental
Arm Description
Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Arm Title
Cadazolid 500 mg
Arm Type
Experimental
Arm Description
Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Arm Title
Cadazolid 1000 mg
Arm Type
Experimental
Arm Description
Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Arm Title
Vancomycin 125 mg
Arm Type
Active Comparator
Arm Description
Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Cadazolid
Other Intervention Name(s)
ACT-179811
Intervention Description
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancomycin hydrochloride
Intervention Description
Vancomycin, provided as capsules (125 mg) for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo-matching cadazolid
Intervention Description
Placebo of cadazolid powder for oral suspension
Intervention Type
Drug
Intervention Name(s)
Placebo-matching vancomycin
Intervention Description
Placebo of vancomycin capsules
Primary Outcome Measure Information:
Title
Clinical cure rate at test-of-cure
Description
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.
Time Frame
Day 13 or 24-72 hours after end of treatment
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Percentages of subjects with recurrence are calculated, with recurrence being defined as the occurrence of diarrhea (> 3 liquid or unformed stools within 24 h associated with positive C. difficile toxin A/B assay) within 4 weeks after EOT in subjects clinically cured (at test-of-cure).
Time Frame
Between Day 13 and Day 41 (within 4 weeks after end of treatment)
Title
Sustained cure rate
Description
Percentages of subjects with sustained cure are calculated, with sustained cure being defined as clinical cure without CDAD recurrence up to the end of study
Time Frame
Between Day 13 and day 41 (within 4 weeks after end of treatment)
Title
Time to resolution of diarrhea
Description
Time to resolution of diarrhea was defined as the time (h) from the first intake of study treatment to the time (occurrence) of the first stool meeting the criteria for resolution of diarrhea up to test-of-cure.
Time Frame
From Day 1 up to Day 13 (or 24-72 hours after end of treatment)
Title
Incidence of treatment-emergent adverse events
Description
Percentage of subjects with any adverse events in each group from first study treatment intake up to 3 days after last study drug intake
Time Frame
From Day 1 to Day 14
Title
Adverse events leading to premature discontinuation of study treatment
Description
Number of patients in each group who discontinued the study treatment due to an adverse event
Time Frame
Up to Day 10
Other Pre-specified Outcome Measures:
Title
Modified clinical cure rate
Description
Percentage of subjects with modified clinical cure (mCC) is reported, with mCC defined as the occurrence of ≤ 3 liquid or unformed stools and any number of semi-formed or formed stools per day for at least two consecutive days, and thereafter maintained up to TOC visit. In addition, no concomitant medication active against CDAD received from the start of study treatment up to TOC
Time Frame
Day 13 or 24-72 hours after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female At least 18 years of age With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence. Key Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Charef, DVM
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigative Site 6902
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Clinical Investigative Site 6919
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Clinical Investigative Site 6938
City
Orlando
State/Province
Florida
ZIP/Postal Code
32837
Country
United States
Facility Name
Clinical Investigative Site 6930
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Clinical Investigative Site 6935
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Clinical Investigative Site 6915
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Clinical Investigative Site 6906
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Clinical Investigative Site 6917
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Clinical Investigative Site 6936
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Clinical Investigative Site 6903
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Clinical Investigative Site 6914
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Investigative Site 6605
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Clinical Investigative Site 6601
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Clinical Investigative Site 6606
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Clinical Ivestigative Site 6602
City
Calgary
ZIP/Postal Code
T2N2T8
Country
Canada
Facility Name
Clinical Investigative Site 6632
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Clinical Investigative Site 6633
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Clinical Investigative Site 6634
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Clinical Investigative Site 6734
City
Busto Arsizio
ZIP/Postal Code
21052
Country
Italy
Facility Name
Clinical Investigative Site 6735
City
Modena
ZIP/Postal Code
4114
Country
Italy
Facility Name
Clinical Investigative Site 6702
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Clinical Investigative Site 6801
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Clinical Investigative Site 6804
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26248357
Citation
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.
Results Reference
result
PubMed Identifier
26433782
Citation
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.
Results Reference
result

Learn more about this trial

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

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