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

Clostridium Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222702
• Other study ID #: AC-061A201
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2010
• Last updated: June 9, 2017
• Start date: January 25, 2011
• Est. completion date: November 12, 2012

Study information

• Verified date: June 2017
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 further clinical development of the compound in subjects with CDAD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 12, 2012
• Est. primary completion date: October 16, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Diarrhea

Intervention

Drug:
• Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
• Vancomycin
Vancomycin, provided as capsules (125 mg) for oral administration
• Placebo-matching cadazolid
Placebo of cadazolid powder for oral suspension
• Placebo-matching vancomycin
Placebo of vancomycin capsules

Locations

Country	Name	City	State
Canada	Clinical Ivestigative Site 6602	Calgary
Canada	Clinical Investigative Site 6601	Montreal	Quebec
Canada	Clinical Investigative Site 6606	Sherbrooke	Quebec
Canada	Clinical Investigative Site 6605	Victoria	British Columbia
Germany	Clinical Investigative Site 6632	Koln
Germany	Clinical Investigative Site 6633	Regensburg
Germany	Clinical Investigative Site 6634	Ulm
Italy	Clinical Investigative Site 6734	Busto Arsizio
Italy	Clinical Investigative Site 6735	Modena
Sweden	Clinical Investigative Site 6702	Orebro
United Kingdom	Clinical Investigative Site 6801	Blackpool
United Kingdom	Clinical Investigative Site 6804	York
United States	Clinical Investigative Site 6917	Boston	Massachusetts
United States	Clinical Investigative Site 6906	Chicago	Illinois
United States	Clinical Investigative Site 6903	Columbus	Ohio
United States	Clinical Investigative Site 6930	Decatur	Georgia
United States	Clinical Investigative Site 6914	Houston	Texas
United States	Clinical Investigative Site 6915	Idaho Falls	Idaho
United States	Clinical Investigative Site 6919	Jacksonville	Florida
United States	Clinical Investigative Site 6935	Marietta	Georgia
United States	Clinical Investigative Site 6902	Newark	Delaware
United States	Clinical Investigative Site 6938	Orlando	Florida
United States	Clinical Investigative Site 6936	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Sweden,  United Kingdom, 

References & Publications (2)

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 — View 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 Age — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified clinical cure rate	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	Day 13 or 24-72 hours after end of treatment
Primary	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	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).	Between Day 13 and Day 41 (within 4 weeks after end of treatment)
Secondary	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	Between Day 13 and day 41 (within 4 weeks after end of treatment)
Secondary	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.	From Day 1 up to Day 13 (or 24-72 hours after end of treatment)
Secondary	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	From Day 1 to Day 14
Secondary	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	Up to Day 10