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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Antimicrob+Agents+Chemother
2015 ; 59
(10
): 6266-73
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gab.com Text
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Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel
Antibiotic Cadazolid in Patients with Clostridium difficile Infection
#MMPMID26248357
Louie T
; Nord CE
; Talbot GH
; Wilcox M
; Gerding DN
; Buitrago M
; Kracker H
; Charef P
; Cornely OA
Antimicrob Agents Chemother
2015[Oct]; 59
(10
): 6266-73
PMID26248357
show ga
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.).
|Administration, Oral
[MESH]
|Adult
[MESH]
|Aged
[MESH]
|Anti-Bacterial Agents/pharmacokinetics/*therapeutic use
[MESH]