Clostridium Difficile InfectionPhase 2NCT01222702
Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
A Phase 2 study testing Cadazolid and Vancomycin in people with Clostridium Difficile Infection, run by Actelion at 23 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Cadazolid and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 25 Jan 2011to 12 Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- At least 18 years of age
- With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.
Who cannot join
- 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
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States11 sites
Clinical Investigative Site 6917
Boston, Massachusetts, 02111
Clinical Investigative Site 6906
Chicago, Illinois, 60637
Clinical Investigative Site 6903
Columbus, Ohio, 43215
Clinical Investigative Site 6930
Decatur, Georgia, 30033
Clinical Investigative Site 6914
Houston, Texas, 77030
Clinical Investigative Site 6915
Idaho Falls, Idaho, 83404
Clinical Investigative Site 6919
Jacksonville, Florida, 32207
Clinical Investigative Site 6935
Marietta, Georgia, 30060
Clinical Investigative Site 6902
Newark, Delaware, 19718
Clinical Investigative Site 6938
Orlando, Florida, 32837
Clinical Investigative Site 6936
Royal Oak, Michigan, 48073
Canada4 sites
Clinical Ivestigative Site 6602
Calgary, T2N2T8
Clinical Investigative Site 6601
Montreal, Quebec, H3T 1E2
Clinical Investigative Site 6606
Sherbrooke, Quebec, J1H5N4
Clinical Investigative Site 6605
Victoria, British Columbia, V8R 1J8
Germany3 sites
Clinical Investigative Site 6632
Cologne, 50937
Clinical Investigative Site 6633
Regensburg, 93042
Clinical Investigative Site 6634
Ulm, 89081
Italy2 sites
Clinical Investigative Site 6734
Busto Arsizio, 21052
Clinical Investigative Site 6735
Modena, 4114
United Kingdom2 sites
Clinical Investigative Site 6801
Blackpool, FY3 8NR
Clinical Investigative Site 6804
York, YO31 8HE
About this study
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)
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
- Being tested
- Cadazolid, Vancomycin, Placebo-matching cadazolid, Placebo-matching vancomycin
- Keywords
- CDIFF, CDAD, CDI, Clostridium difficile infection
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadazolidDrug
Also called ACT-179811
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
VancomycinDrug
Also called Vancomycin hydrochloride
Vancomycin, provided as capsules (125 mg) for oral administration
Placebo-matching cadazolidDrug
Placebo of cadazolid powder for oral suspension
Placebo-matching vancomycinDrug
Placebo of vancomycin capsules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Vancomycin; Drug: Placebo-matching cadazolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 13 or 24-72 hours after end of treatment
Secondary outcomes (5)
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).
Measured: Between Day 13 and Day 41 (within 4 weeks after end of treatment)
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
Measured: Between Day 13 and day 41 (within 4 weeks after end of treatment)
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.
Measured: From Day 1 up to Day 13 (or 24-72 hours after end of treatment)
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
Measured: From Day 1 to Day 14
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
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study start25 Jan 2011
- Primary completion16 Oct 2012
- Study completion12 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Charef, DVM, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222702
- Sponsor's protocol ID
- AC-061A201
- Status last verified
- Jun 2017
- First submitted
- 8 Oct 2010
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 26248357Gerding 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.
PubMed 26433782
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01222702
- Acronym / sponsor ID
- AC-061A201
- Conditions
- Clostridium Difficile Infection
- Keywords
- CDIFF, CDAD, CDI, Clostridium difficile infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2011 (actual)
- Primary completion
- 16 Oct 2012 (actual)
- Study completion
- 12 Nov 2012 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cadazolid 250 mg | Experimental | Drug: Cadazolid, Drug: Placebo-matching vancomycinSubjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days |
| Cadazolid 500 mg | Experimental | Drug: Cadazolid, Drug: Placebo-matching vancomycinSubjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days |
| Cadazolid 1000 mg | Experimental | Drug: Cadazolid, Drug: Placebo-matching vancomycinSubjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days |
| Vancomycin 125 mg | Active comparator | Drug: Vancomycin, Drug: Placebo-matching cadazolidSubjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CadazolidAlso: ACT-179811Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration | Drug | Cadazolid 1000 mg, Cadazolid 250 mg, Cadazolid 500 mg |
| VancomycinAlso: Vancomycin hydrochlorideVancomycin, provided as capsules (125 mg) for oral administration | Drug | Vancomycin 125 mg |
| Placebo-matching cadazolidPlacebo of cadazolid powder for oral suspension | Drug | Vancomycin 125 mg |
| Placebo-matching vancomycinPlacebo of vancomycin capsules | Drug | Cadazolid 1000 mg, Cadazolid 250 mg, Cadazolid 500 mg |
Primary outcome
Clinical cure rate at test-of-cure
Time frame: Day 13 or 24-72 hours after end of treatment
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.
5 secondary outcomes
Recurrence rate
Time frame: Between Day 13 and Day 41 (within 4 weeks after end of treatment)
Sustained cure rate
Time frame: Between Day 13 and day 41 (within 4 weeks after end of treatment)
Time to resolution of diarrhea
Time frame: From Day 1 up to Day 13 (or 24-72 hours after end of treatment)
Incidence of treatment-emergent adverse events
Time frame: From Day 1 to Day 14
Adverse events leading to premature discontinuation of study treatment
Time frame: Up to Day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Results publication: PubMed 26248357Louie 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 publication: PubMed 26433782Gerding 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Charef, DVM study director
Actelion
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadazolid and Vancomycin in people with Clostridium Difficile Infection, run by Actelion at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada, Germany, Italy, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate at test-of-cure (time frame: Day 13 or 24-72 hours after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01222702, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.