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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadazolid | Drug | Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Charef, DVM | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigative Site 6902 | Newark | Delaware | 19718 | United States | ||
| Clinical Investigative Site 6919 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26248357 | Result | 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. | |
| 26433782 |
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|
| Vancomycin | Drug | Vancomycin, provided as capsules (125 mg) for oral administration |
|
|
| Placebo-matching cadazolid | Drug | Placebo of cadazolid powder for oral suspension |
|
| Placebo-matching vancomycin | Drug | Placebo of vancomycin capsules |
|
| 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) |
| 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) |
| 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 |
| 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 |
| Day 13 or 24-72 hours after end of treatment |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Clinical Investigative Site 6938 | Orlando | Florida | 32837 | United States |
| Clinical Investigative Site 6930 | Decatur | Georgia | 30033 | United States |
| Clinical Investigative Site 6935 | Marietta | Georgia | 30060 | United States |
| Clinical Investigative Site 6915 | Idaho Falls | Idaho | 83404 | United States |
| Clinical Investigative Site 6906 | Chicago | Illinois | 60637 | United States |
| Clinical Investigative Site 6917 | Boston | Massachusetts | 02111 | United States |
| Clinical Investigative Site 6936 | Royal Oak | Michigan | 48073 | United States |
| Clinical Investigative Site 6903 | Columbus | Ohio | 43215 | United States |
| Clinical Investigative Site 6914 | Houston | Texas | 77030 | United States |
| Clinical Investigative Site 6605 | Victoria | British Columbia | V8R 1J8 | Canada |
| Clinical Investigative Site 6601 | Montreal | Quebec | H3T 1E2 | Canada |
| Clinical Investigative Site 6606 | Sherbrooke | Quebec | J1H5N4 | Canada |
| Clinical Ivestigative Site 6602 | Calgary | T2N2T8 | Canada |
| Clinical Investigative Site 6632 | Cologne | 50937 | Germany |
| Clinical Investigative Site 6633 | Regensburg | 93042 | Germany |
| Clinical Investigative Site 6634 | Ulm | 89081 | Germany |
| Clinical Investigative Site 6734 | Busto Arsizio | 21052 | Italy |
| Clinical Investigative Site 6735 | Modena | 4114 | Italy |
| Clinical Investigative Site 6702 | Örebro | 70185 | Sweden |
| Clinical Investigative Site 6801 | Blackpool | FY3 8NR | United Kingdom |
| Clinical Investigative Site 6804 | York | YO31 8HE | United Kingdom |
| 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. |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000591679 | cadazolid |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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