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

January 31, 2025 updated by: Actelion

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).

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
631

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, 5000
        • Investigator Site
      • La Plata, Argentina, 1900
        • Investigator Site
  • Belgium
      • Brussels, Belgium, 1200
        • Investigator Site
      • Bruxelles, Belgium, 1000
        • Investigator Site
      • Gent, Belgium, 9000
        • Investigator Site
      • Leuven, Belgium, 3000
        • Investigator Site
  • Brazil
      • Belo Horizonte, Brazil, 30150
        • Investigator Site
      • Porto Alegre, Brazil, 90160-093
        • Investigator Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Investigator Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Investigator Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Investigator Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Investigator Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Investigator Site
      • Trois-Rivieres, Quebec, Canada, G8Z 3R9
        • Investigator Site
  • Chile
      • Santiago, Chile, 7560171
        • Investigator Site
      • Santiago, Chile, 8431657
        • Investigator Site
  • Croatia
      • Pozega, Croatia, 34000
        • Investigator Site 2788
      • Zagreb, Croatia, 10 000
        • Investigator Site 2780
      • Zagreb, Croatia, 10 000
        • Investigator Site 2781
      • Zagreb, Croatia, 10 000
        • Investigator Site 2784
      • Zagreb, Croatia, 10 000
        • Investigator Site 2785
      • Zagreb, Croatia, 10 001
        • Investigator Site 2786
  • Czechia
      • Brno, Czechia, 625 00
        • Investigator Site
      • Opava, Czechia, 746 01
        • Investigator Site
      • Ostrava, Czechia, 708 52
        • Investigator Site
      • Praha, Czechia, 150 06
        • Investigator Site
      • Praha 4, Czechia, 140 21
        • Investigator Site
  • Greece
      • Athens, Greece, 10676
        • Investigator Site
      • Athens, Greece, 12462
        • Investigator Site
      • Athens, Greece
        • Investigator Site
      • Piraeus, Greece, 18536
        • Investigator Site
  • Hungary
      • Budapest, Hungary, 1088
        • Investigator Site
      • Debrecen, Hungary, 4043
        • Investigator Site
      • Szekszard, Hungary, 7100
        • Investigator Site
  • Israel
      • Hadera, Israel, 38100
        • Investigator Site
      • Haifa, Israel, 31096
        • Investigator Site
      • Holon, Israel, 58100
        • Investigator Site
      • Jerusalem, Israel, 91120
        • Investigator Site
      • Kfar Saba, Israel, 44281
        • Investigator Site
      • Petach Tikva, Israel, 49100
        • Investigator Site
      • Ramat-Gan, Israel, 52621
        • Investigator Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Investigator Site
      • Seoul, Korea, Republic of, 136-705
        • Investigator Site
      • Seoul, Korea, Republic of, 158-710
        • Investigator Site
  • Romania
      • Bucharest, Romania, 021105
        • Investigator Site
      • Bucharest, Romania, 021659
        • Investigator Site
      • Cluj-Napoca, Romania, 40000
        • Investigator Site
      • Galati, Romania, 800179
        • Investigator Site
      • Iasi, Romania, 700116
        • Investigator Site
  • Slovakia
      • Bratislava, Slovakia, 950 01
        • Investigator Site
      • Nitra, Slovakia, 833 05
        • Investigator Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-0006
        • Investigator Site
    • California
      • Laguna Hills, California, United States, 92653
        • Investigator Site
      • Mission Hills, California, United States, 91345
        • Investigator Site
      • Rialto, California, United States, 92377
        • Investigator Site
    • Florida
      • Orlando, Florida, United States, 32803
        • Investigator Site
      • Pensacola, Florida, United States, 32504
        • Investigator Site
      • Port Saint Lucie, Florida, United States, 34987
        • Investigator Site
      • Stuart, Florida, United States, 34994
        • Investigator Site
      • Weston, Florida, United States, 33331
        • Investigator Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Investigator Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Investigator Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Investigator Site
      • Shreveport, Louisiana, United States, 71103
        • Investigator Site
    • Maine
      • Lewiston, Maine, United States, 04240
        • Investigator Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Investigator Site
    • Massachusetts
      • Framingham, Massachusetts, United States, 01701
        • Investigator Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Investigator Site
      • Detroit, Michigan, United States, 48202
        • Investigator Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Investigator Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Investigator Site
    • Montana
      • Butte, Montana, United States, 59701
        • Investigator Site
    • New York
      • Brooklyn, New York, United States, 11215
        • Investigator Site
      • Buffalo, New York, United States, 14215
        • Investigator Site
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Investigator Site
      • Jacksonville, North Carolina, United States, 28546
        • Investigator Site
      • Kinston, North Carolina, United States, 28501
        • Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 68198-5456
        • Investigator Site
      • Mentor, Ohio, United States, 44060
        • Investigator Site
      • Toledo, Ohio, United States, 43608
        • Investigator Site
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Investigator Site
      • Philadelphia, Pennsylvania, United States, 19101-4206
        • Investigator Site
    • Texas
      • Cypress, Texas, United States, 77433
        • Investigator Site
      • Dallas, Texas, United States, 75235-9173
        • Investigator Site
      • Houston, Texas, United States, 77025
        • Investigator Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Investigator Site
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Investigator Site
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Investigator Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cadazolid
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Drug: Cadazolid
Cadazolid 250 mg as oral suspension twice daily.
Other Names:
  • ACT-179811
Drug: Vancomycin-matching placebo
Placebo capsules matching vancomycin and administered orally 4 times per day
Active Comparator: Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Drug: Cadazolid-matching placebo
Placebo matching cadazolid and administered orally twice daily
Drug: Vancomycin
Vancomycin 125 mg as oral capsules 4 times daily
Other Names:
  • Vancocin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Cure Rate (CCR) in the Per-protocol Population
Time Frame: Up to Day 12 on average (end-of-treatment + 2 days)
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.
Up to Day 12 on average (end-of-treatment + 2 days)
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Time Frame: Up to Day 12 on average (end-of-treatment + 2 days)
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.
Up to Day 12 on average (end-of-treatment + 2 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population
Time Frame: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
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).
Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)
Time Frame: Up to Day 10

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.
Up to Day 10
Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
Time Frame: Baseline to End of Treatment (10 days after starting study drug) + 2 days
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.
Baseline to End of Treatment (10 days after starting study drug) + 2 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population
Time Frame: Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)
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.
Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)
Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population
Time Frame: Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)
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.
Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)
Sustained Cure Rate (SCR) in the Per-protocol Population
Time Frame: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
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.
Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
Recurrence Rate
Time Frame: Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)
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.
Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)
Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5
Time Frame: Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)
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).
Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne Claire Marrast, MD, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-061A302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings