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Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cadazolid
Vancomycin
Cadazolid-matching placebo
Vancomycin-matching placebo
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 Clostridium difficile infection, Post-antibiotic diarrhea

Eligibility Criteria

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

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.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Sites / Locations

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  • Investigator Site 2788
  • Investigator Site 2780
  • Investigator Site 2781
  • Investigator Site 2784
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  • Investigator Site 2786
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cadazolid

Vancomycin

Arm Description

Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days

Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days

Outcomes

Primary Outcome Measures

Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.
Clinical Cure Rate (CCR) in the Per-protocol Population
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.

Secondary Outcome Measures

Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population
Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)
Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment. The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point.
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms.

Full Information

First Posted
November 7, 2013
Last Updated
April 26, 2018
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT01983683
Brief Title
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2013 (Actual)
Primary Completion Date
March 9, 2017 (Actual)
Study Completion Date
May 2, 2017 (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
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
Detailed Description
Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile infection, Post-antibiotic diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
631 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cadazolid
Arm Type
Experimental
Arm Description
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Intervention Type
Drug
Intervention Name(s)
Cadazolid
Other Intervention Name(s)
ACT-179811
Intervention Description
Cadazolid 250 mg as oral suspension twice daily.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
Vancocin
Intervention Description
Vancomycin 125 mg as oral capsules 4 times daily
Intervention Type
Drug
Intervention Name(s)
Cadazolid-matching placebo
Intervention Description
Placebo matching cadazolid and administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Vancomycin-matching placebo
Intervention Description
Placebo capsules matching vancomycin and administered orally 4 times per day
Primary Outcome Measure Information:
Title
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Description
Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.
Time Frame
Up to Day 12 on average (end-of-treatment + 2 days)
Title
Clinical Cure Rate (CCR) in the Per-protocol Population
Description
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.
Time Frame
Up to Day 12 on average (end-of-treatment + 2 days)
Secondary Outcome Measure Information:
Title
Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population
Description
Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).
Time Frame
Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
Title
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)
Description
Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment. The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point.
Time Frame
Up to Day 10
Title
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
Description
CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms.
Time Frame
Baseline to End of Treatment (10 days after starting study drug) + 2 days
Other Pre-specified Outcome Measures:
Title
Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population
Description
ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.
Time Frame
Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)
Title
Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population
Description
ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.
Time Frame
Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)
Title
Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5
Description
ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis. ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT).
Time Frame
Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)
Title
Sustained Cure Rate (SCR) in the Per-protocol Population
Description
Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.
Time Frame
Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
Title
Recurrence Rate
Description
Recurrence is defined as the occurrence of a new episode of diarrhea (> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.
Time Frame
Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Claire Marrast, MD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-0006
Country
United States
Facility Name
Investigator Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Investigator Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigator Site
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Investigator Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Investigator Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Investigator Site
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34987
Country
United States
Facility Name
Investigator Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Investigator Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Investigator Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Investigator Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Investigator Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Investigator Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Investigator Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Investigator Site
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
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United States
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Investigator Site
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Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
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United States
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Investigator Site
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Framingham
State/Province
Massachusetts
ZIP/Postal Code
01701
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United States
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Investigator Site
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Detroit
State/Province
Michigan
ZIP/Postal Code
48201
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United States
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Investigator Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
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United States
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Investigator Site
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Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
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United States
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Investigator Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
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United States
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Investigator Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
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United States
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Investigator Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
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United States
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Investigator Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
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United States
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Investigator Site
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Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
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Investigator Site
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
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Investigator Site
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Investigator Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
68198-5456
Country
United States
Facility Name
Investigator Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Investigator Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Investigator Site
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Investigator Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19101-4206
Country
United States
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Investigator Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
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United States
Facility Name
Investigator Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9173
Country
United States
Facility Name
Investigator Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Investigator Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Investigator Site
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Investigator Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Investigator Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Investigator Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Investigator Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Investigator Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigator Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Investigator Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigator Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigator Site
City
Belo Horizonte
ZIP/Postal Code
30150
Country
Brazil
Facility Name
Investigator Site
City
Porto Alegre
ZIP/Postal Code
90160-093
Country
Brazil
Facility Name
Investigator Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Investigator Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
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Canada
Facility Name
Investigator Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
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Canada
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Investigator Site
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London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
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Canada
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Investigator Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
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Canada
Facility Name
Investigator Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Investigator Site
City
Santiago
ZIP/Postal Code
7560171
Country
Chile
Facility Name
Investigator Site
City
Santiago
ZIP/Postal Code
8431657
Country
Chile
Facility Name
Investigator Site 2788
City
Pozega
ZIP/Postal Code
34000
Country
Croatia
Facility Name
Investigator Site 2780
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Investigator Site 2781
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Investigator Site 2784
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Investigator Site 2785
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Investigator Site 2786
City
Zagreb
ZIP/Postal Code
10 001
Country
Croatia
Facility Name
Investigator Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Investigator Site
City
Opava
ZIP/Postal Code
746 01
Country
Czechia
Facility Name
Investigator Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Investigator Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Investigator Site
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Investigator Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Investigator Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Investigator Site
City
Athens
Country
Greece
Facility Name
Investigator Site
City
Piraeus
ZIP/Postal Code
18536
Country
Greece
Facility Name
Investigator Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Investigator Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Investigator Site
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Investigator Site
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Investigator Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Investigator Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Investigator Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigator Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Investigator Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Investigator Site
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigator Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigator Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Investigator Site
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Investigator Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Facility Name
Investigator Site
City
Bucharest
ZIP/Postal Code
021659
Country
Romania
Facility Name
Investigator Site
City
Cluj-Napoca
ZIP/Postal Code
40000
Country
Romania
Facility Name
Investigator Site
City
Galati
ZIP/Postal Code
800179
Country
Romania
Facility Name
Investigator Site
City
Iasi
ZIP/Postal Code
700116
Country
Romania
Facility Name
Investigator Site
City
Bratislava
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Investigator Site
City
Nitra
ZIP/Postal Code
833 05
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30709665
Citation
Gerding DN, Cornely OA, Grill S, Kracker H, Marrast AC, Nord CE, Talbot GH, Buitrago M, Gheorghe Diaconescu I, Murta de Oliveira C, Preotescu L, Pullman J, Louie TJ, Wilcox MH. Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials. Lancet Infect Dis. 2019 Mar;19(3):265-274. doi: 10.1016/S1473-3099(18)30614-5. Epub 2019 Jan 29.
Results Reference
derived
PubMed Identifier
29680101
Citation
Kleinman L, Talbot GH, Hunsche E, Schuler R, Nord CE. The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium difficile Infection. Value Health. 2018 Apr;21(4):441-448. doi: 10.1016/j.jval.2017.08.3017. Epub 2017 Nov 7.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

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