Universität zu Köln

Louie, Thomas, Nord, Carl Erik, Talbot, George H., Wilcox, Mark, Gerding, Dale N., Buitrago, Martha, Kracker, Hilke, Charef, Pascal and Cornely, Oliver A. (2015). Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic Cadazolid in Patients with Clostridium difficile Infection. Antimicrob. Agents Chemother., 59 (10). S. 6266 - 6274. WASHINGTON: AMER SOC MICROBIOLOGY. ISSN 1098-6596

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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 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 250, 500, or 1,000 mg cadazolid twice daily (BID) or oral 125 mg vancomycin four times daily (QID) for 10 days. The primary endpoint was clinical cure at test of cure (48 +/- 24 h after the end of treatment; modified intent-to-treat population), defined as resolution of diarrhea with 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 250, 500, or 1,000 mg cadazolid BID or 125 mg vancomycin QID, respectively. The primary endpoint was achieved in 76.5% (80% confidence interval [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 lower recurrence rate than with vancomycin (18.2 to 25.0% versus 50%). Consequently, higher sustained clinical response rates were observed with cadazolid (46.7 to 60.0%) than with vancomycin (33.3%). The times to diarrhea resolution were similar for 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. (This study has been registered in the United States at ClinicalTrials.gov under registration no. NCT01222702 and in Europe with the European Medicines Agency under registration no. EUDRA-CT 2010-020941-29.)

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Louie, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Nord, Carl Erik UNSPECIFIED UNSPECIFIED UNSPECIFIED Talbot, George H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wilcox, Mark UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerding, Dale N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Buitrago, Martha UNSPECIFIED UNSPECIFIED UNSPECIFIED Kracker, Hilke UNSPECIFIED UNSPECIFIED UNSPECIFIED Charef, Pascal UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-390247
DOI:	10.1128/AAC.00504-15
Journal or Publication Title:	Antimicrob. Agents Chemother.
Volume:	59
Number:	10
Page Range:	S. 6266 - 6274
Date:	2015
Publisher:	AMER SOC MICROBIOLOGY
Place of Publication:	WASHINGTON
ISSN:	1098-6596
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TREATMENT OPTIONS; IN-VITRO; EPIDEMIOLOGY; RESISTANCE; DISEASE Multiple languages Microbiology; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39024