Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]

Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A.
The American Society for Microbiology (ASM)
Published 2018

Publication Date:	2018-03-28
Publisher:	The American Society for Microbiology (ASM)
Print ISSN:	0066-4804
Electronic ISSN:	1098-6596
Topics:	Biology Medicine
Published by:	http://www.asm.org/

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autor	Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A.
beschreibung	Two phase II studies were performed with patients with uncomplicated urinary tract infections (uUTIs) and complicated urinary tract infections (cUTIs) or acute pyelonephritis (PN) to compare finafloxacin (300 mg twice a day [b.i.d.] orally for uUTI and 800 mg once a day [q.d.] intravenously [i.v.] for cUTI/PN) and ciprofloxacin (250 mg b.i.d. orally for uUTI and 400 mg b.i.d. i.v. for cUTI/PN). The early response to the study medications was evaluated in the microbiological intent-to-treat population (mITT) at day 3. A total of 21% of the isolates were ciprofloxacin resistant, 13.7% were primed pathogens carrying a mutation(s) potentially fostering fluoroquinolone resistance development, and 7.1% produced extended-spectrum β-lactamases (ESBLs). Finafloxacin demonstrated very good early clinical activity, with microbiological eradication rates of 88.6% ( n = 132), compared to 78.7% ( n = 61) for ciprofloxacin, and 69.6% ( n = 23), compared to 35.7% ( n = 14) for ciprofloxacin, in patients with ciprofloxacin-resistant uropathogens; 94.1% ( n = 17), compared to 80.0% ( n = 10) for ciprofloxacin, in patients infected with uropathogens primed for fluoroquinolone resistance uropathogens; and 91.7% ( n = 11), compared to 0% for ciprofloxacin, in patients infected with ESBL producers. Finafloxacin demonstrated early and rapid activity against uropathogens, including fluoroquinolone-resistant and/or multiresistant pathogens or ESBL producers, while ciprofloxacin was less active against this subset of resistant pathogens. Susceptibilities of pathogens were quantitated by broth microdilution. Isolates were subgrouped according to their susceptibility patterns, in particular first-step quinolone resistance, quinolone resistance, and ESBL production. Eradication was defined as the elimination or reduction of study entry pathogens to 〈10 3 CFU/ml in urine culture. (The studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT00722735 and NCT01928433.)
citation_standardnr	6218900
datenlieferant	ipn_articles
feed_id	515
feed_publisher	The American Society for Microbiology (ASM)
feed_publisher_url	http://www.asm.org/
insertion_date	2018-03-28
journaleissn	1098-6596
journalissn	0066-4804
publikationsjahr_anzeige	2018
publikationsjahr_facette	2018
publikationsjahr_intervall	7984:2015-2019
publikationsjahr_sort	2018
publisher	The American Society for Microbiology (ASM)
quelle	Antimicrobial Agents and Chemotherapy
relation	http://aac.asm.org/cgi/content/short/62/4/e02325-17?rss=1
search_space	articles
shingle_author_1	Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A.
shingle_author_2	Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A.
shingle_author_3	Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A.
shingle_author_4	Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A.
shingle_catch_all_1	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics] Two phase II studies were performed with patients with uncomplicated urinary tract infections (uUTIs) and complicated urinary tract infections (cUTIs) or acute pyelonephritis (PN) to compare finafloxacin (300 mg twice a day [b.i.d.] orally for uUTI and 800 mg once a day [q.d.] intravenously [i.v.] for cUTI/PN) and ciprofloxacin (250 mg b.i.d. orally for uUTI and 400 mg b.i.d. i.v. for cUTI/PN). The early response to the study medications was evaluated in the microbiological intent-to-treat population (mITT) at day 3. A total of 21% of the isolates were ciprofloxacin resistant, 13.7% were primed pathogens carrying a mutation(s) potentially fostering fluoroquinolone resistance development, and 7.1% produced extended-spectrum β-lactamases (ESBLs). Finafloxacin demonstrated very good early clinical activity, with microbiological eradication rates of 88.6% ( n = 132), compared to 78.7% ( n = 61) for ciprofloxacin, and 69.6% ( n = 23), compared to 35.7% ( n = 14) for ciprofloxacin, in patients with ciprofloxacin-resistant uropathogens; 94.1% ( n = 17), compared to 80.0% ( n = 10) for ciprofloxacin, in patients infected with uropathogens primed for fluoroquinolone resistance uropathogens; and 91.7% ( n = 11), compared to 0% for ciprofloxacin, in patients infected with ESBL producers. Finafloxacin demonstrated early and rapid activity against uropathogens, including fluoroquinolone-resistant and/or multiresistant pathogens or ESBL producers, while ciprofloxacin was less active against this subset of resistant pathogens. Susceptibilities of pathogens were quantitated by broth microdilution. Isolates were subgrouped according to their susceptibility patterns, in particular first-step quinolone resistance, quinolone resistance, and ESBL production. Eradication was defined as the elimination or reduction of study entry pathogens to <10 3 CFU/ml in urine culture. (The studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT00722735 and NCT01928433.) Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A. The American Society for Microbiology (ASM) 0066-4804 00664804 1098-6596 10986596
shingle_catch_all_2	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics] Two phase II studies were performed with patients with uncomplicated urinary tract infections (uUTIs) and complicated urinary tract infections (cUTIs) or acute pyelonephritis (PN) to compare finafloxacin (300 mg twice a day [b.i.d.] orally for uUTI and 800 mg once a day [q.d.] intravenously [i.v.] for cUTI/PN) and ciprofloxacin (250 mg b.i.d. orally for uUTI and 400 mg b.i.d. i.v. for cUTI/PN). The early response to the study medications was evaluated in the microbiological intent-to-treat population (mITT) at day 3. A total of 21% of the isolates were ciprofloxacin resistant, 13.7% were primed pathogens carrying a mutation(s) potentially fostering fluoroquinolone resistance development, and 7.1% produced extended-spectrum β-lactamases (ESBLs). Finafloxacin demonstrated very good early clinical activity, with microbiological eradication rates of 88.6% ( n = 132), compared to 78.7% ( n = 61) for ciprofloxacin, and 69.6% ( n = 23), compared to 35.7% ( n = 14) for ciprofloxacin, in patients with ciprofloxacin-resistant uropathogens; 94.1% ( n = 17), compared to 80.0% ( n = 10) for ciprofloxacin, in patients infected with uropathogens primed for fluoroquinolone resistance uropathogens; and 91.7% ( n = 11), compared to 0% for ciprofloxacin, in patients infected with ESBL producers. Finafloxacin demonstrated early and rapid activity against uropathogens, including fluoroquinolone-resistant and/or multiresistant pathogens or ESBL producers, while ciprofloxacin was less active against this subset of resistant pathogens. Susceptibilities of pathogens were quantitated by broth microdilution. Isolates were subgrouped according to their susceptibility patterns, in particular first-step quinolone resistance, quinolone resistance, and ESBL production. Eradication was defined as the elimination or reduction of study entry pathogens to <10 3 CFU/ml in urine culture. (The studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT00722735 and NCT01928433.) Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A. The American Society for Microbiology (ASM) 0066-4804 00664804 1098-6596 10986596
shingle_catch_all_3	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics] Two phase II studies were performed with patients with uncomplicated urinary tract infections (uUTIs) and complicated urinary tract infections (cUTIs) or acute pyelonephritis (PN) to compare finafloxacin (300 mg twice a day [b.i.d.] orally for uUTI and 800 mg once a day [q.d.] intravenously [i.v.] for cUTI/PN) and ciprofloxacin (250 mg b.i.d. orally for uUTI and 400 mg b.i.d. i.v. for cUTI/PN). The early response to the study medications was evaluated in the microbiological intent-to-treat population (mITT) at day 3. A total of 21% of the isolates were ciprofloxacin resistant, 13.7% were primed pathogens carrying a mutation(s) potentially fostering fluoroquinolone resistance development, and 7.1% produced extended-spectrum β-lactamases (ESBLs). Finafloxacin demonstrated very good early clinical activity, with microbiological eradication rates of 88.6% ( n = 132), compared to 78.7% ( n = 61) for ciprofloxacin, and 69.6% ( n = 23), compared to 35.7% ( n = 14) for ciprofloxacin, in patients with ciprofloxacin-resistant uropathogens; 94.1% ( n = 17), compared to 80.0% ( n = 10) for ciprofloxacin, in patients infected with uropathogens primed for fluoroquinolone resistance uropathogens; and 91.7% ( n = 11), compared to 0% for ciprofloxacin, in patients infected with ESBL producers. Finafloxacin demonstrated early and rapid activity against uropathogens, including fluoroquinolone-resistant and/or multiresistant pathogens or ESBL producers, while ciprofloxacin was less active against this subset of resistant pathogens. Susceptibilities of pathogens were quantitated by broth microdilution. Isolates were subgrouped according to their susceptibility patterns, in particular first-step quinolone resistance, quinolone resistance, and ESBL production. Eradication was defined as the elimination or reduction of study entry pathogens to <10 3 CFU/ml in urine culture. (The studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT00722735 and NCT01928433.) Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A. The American Society for Microbiology (ASM) 0066-4804 00664804 1098-6596 10986596
shingle_catch_all_4	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics] Two phase II studies were performed with patients with uncomplicated urinary tract infections (uUTIs) and complicated urinary tract infections (cUTIs) or acute pyelonephritis (PN) to compare finafloxacin (300 mg twice a day [b.i.d.] orally for uUTI and 800 mg once a day [q.d.] intravenously [i.v.] for cUTI/PN) and ciprofloxacin (250 mg b.i.d. orally for uUTI and 400 mg b.i.d. i.v. for cUTI/PN). The early response to the study medications was evaluated in the microbiological intent-to-treat population (mITT) at day 3. A total of 21% of the isolates were ciprofloxacin resistant, 13.7% were primed pathogens carrying a mutation(s) potentially fostering fluoroquinolone resistance development, and 7.1% produced extended-spectrum β-lactamases (ESBLs). Finafloxacin demonstrated very good early clinical activity, with microbiological eradication rates of 88.6% ( n = 132), compared to 78.7% ( n = 61) for ciprofloxacin, and 69.6% ( n = 23), compared to 35.7% ( n = 14) for ciprofloxacin, in patients with ciprofloxacin-resistant uropathogens; 94.1% ( n = 17), compared to 80.0% ( n = 10) for ciprofloxacin, in patients infected with uropathogens primed for fluoroquinolone resistance uropathogens; and 91.7% ( n = 11), compared to 0% for ciprofloxacin, in patients infected with ESBL producers. Finafloxacin demonstrated early and rapid activity against uropathogens, including fluoroquinolone-resistant and/or multiresistant pathogens or ESBL producers, while ciprofloxacin was less active against this subset of resistant pathogens. Susceptibilities of pathogens were quantitated by broth microdilution. Isolates were subgrouped according to their susceptibility patterns, in particular first-step quinolone resistance, quinolone resistance, and ESBL production. Eradication was defined as the elimination or reduction of study entry pathogens to <10 3 CFU/ml in urine culture. (The studies described in this paper have been registered at ClinicalTrials.gov under identifiers NCT00722735 and NCT01928433.) Vente, A., Bentley, C., Lückermann, M., Tambyah, P., Dalhoff, A. The American Society for Microbiology (ASM) 0066-4804 00664804 1098-6596 10986596
shingle_title_1	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]
shingle_title_2	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]
shingle_title_3	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]
shingle_title_4	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]
timestamp	2025-06-30T23:33:52.711Z
titel	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]
titel_suche	Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates [Clinical Therapeutics]
topic	W WW-YZ
uid	ipn_articles_6218900