A Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic, Cadazolid, in Patients with Clostridium difficile Infection Journal Article

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Authors: Louie, T; Nord, C. E.; Talbot, G. H.; Wilcox, M.; Gerding, D. N.; Buitrago, M.; Kracker, H.; Charef, P.; Cornely, O. A.
Article Title: A Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic, Cadazolid, in Patients with Clostridium difficile Infection
Abstract: Cadazolid, a novel fluoroquinolone-oxazolidinone antibiotic, exhibits potent in vitro activity against Clostridium difficile, including the epidemic BI/NAP1/027 strain. This multicenter, randomized, double-blind, active reference group, phase 2 study (NCT01222702; EUDRA-CT 2010-020941-29) evaluated the efficacy and safety of oral cadazolid in treatment of adult patients with C. difficile infection (CDI). Eligible patients with first occurrence/first recurrence of CDI were randomized 1:1:1:1 to cadazolid 250, 500 or 1000 mg twice daily (BID), or oral vancomycin 125 mg four times daily (QID), for 10 days. The primary endpoint was clinical cure at test-of-cure (48+/-24 h after end-of-treatment; modified intent-to-treat population), defined as resolution of diarrhea and no further CDI treatment required. Secondary endpoints included recurrence rate, sustained clinical response (clinical cure without recurrence) and time to diarrhea resolution. Of 84 patients enrolled, 20, 22, 20 and 22 received cadazolid 250, 500, 1000 mg BID or vancomycin 125 mg QID, respectively. The primary endpoint was achieved in 76.5% (80% CI 58.4, 89.3), 80.0% (63.9, 91.0), 68.4% (51.1, 82.5) and 68.2% (52.3, 81.3) of patients, respectively. There was no evidence of a cadazolid dosage-dependent response. Each dosage of cadazolid resulted in a numerically lower recurrence rate compared with vancomycin (18.2-25.0% vs. 50%). Consequently, numerically higher sustained clinical response rates were observed with cadazolid (46.7-60.0%) compared with vancomycin (33.3%). Time to diarrhea resolution was similar between cadazolid and vancomycin. Cadazolid was well-tolerated with no safety signal observed. The results of this phase 2 study support further clinical development of cadazolid.
Journal Title: Antimicrobial Agents and Chemotherapy
Volume: 59
Issue: 10
ISSN: 1098-6596; 0066-4804
Publisher: American Society for Microbiology. All Rights Reserved  
Date Published: 2015
Start Page: 6266
End Page: 6273
Language: ENG
DOI/URL:

10.1128/AAC.00504-15
Notes: LR: 20150808; CI: Copyright (c) 2015; JID: 0315061; aheadofprint