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  • 1
    In: Clinical Infectious Diseases, 2015, Vol. 61(11), pp.1662-1663
    Keywords: Asymptomactic Bacteriuria ; Recurrent Urinary Tract Infections ; Prophylaxis
    ISSN: 1058-4838
    E-ISSN: 1537-6591
    Source: Oxford University Press
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  • 2
    Language: English
    In: The Lancet, 26 September 2015, Vol.386(10000), pp.1242-1242
    Description: We thank Tom Boyles, Jan Kielstein and Julius Schmidt, and Ciprian Popa and colleagues, for their comments in response to our Article.1 Our trial used a study design that tested intravenous-only therapy, which had both regulatory and clinical precedence. We agree with Boyles that antibiotic stewardship is an important issue and that specific collateral effects can be assessed in such studies, as has been shown in two randomised trials assessing bowel colonisation with resistant Gram-negative bacilli after antimicrobial therapy of intra-abdominal infections with ertapenem versus ceftriaxone-metronidazole.
    Keywords: Medicine
    ISSN: 0140-6736
    E-ISSN: 1474-547X
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  • 3
    Language: English
    In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, September 2012, Vol.55(6), pp.778-80
    Keywords: Secondary Prevention ; Bacterial Infections -- Drug Therapy ; Urinary Tract Infections -- Drug Therapy
    ISSN: 10584838
    E-ISSN: 1537-6591
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  • 4
    Language: English
    In: The Lancet, 16 May 2015, Vol.385(9981), pp.1949-1956
    Description: Treatment of complicated urinary-tract infections is challenging due to rising antimicrobial resistance. We assessed the efficacy and safety of ceftolozane-tazobactam, a novel antibacterial with Gram-negative activity, in the treatment of patients with complicated lower-urinary-tract infections or pyelonephritis. ASPECT-cUTI was a randomised, double-blind, double-dummy, non-inferiority trial done in 209 centres in 25 countries. Between July, 2011, and September, 2013, hospital inpatients aged 18 years or older who had pyuria and a diagnosis of a complicated lower-urinary-tract infection or pyelonephritis were randomly assigned in a 1:1 ratio to receive intravenous 1·5 g ceftolozane-tazobactam every 8 h or intravenous high-dose (750 mg) levofloxacin once daily for 7 days. The randomisation schedule was computer generated in blocks of four and stratified by study site. The next allocation was obtained by the study site pharmacist via an interactive voice-response system. The primary endpoint was a composite of microbiological eradication and clinical cure 5–9 days after treatment in the microbiological modified intention-to-treat (MITT) population, with a non-inferiority margin of 10%. This study is registered with , numbers and . Of 1083 patients enrolled, 800 (73·9%), of whom 656 (82·0%) had pyelonephritis, were included in the microbiological MITT population. Ceftolozane-tazobactam was non-inferior to levofloxacin for composite cure (306 [76·9%] of 398 275 [68·4%] of 402, 95% CI 2·3–14·6) and, as the lower bound of the two-sided 95% CI around the treatment difference was positive and greater than zero, superiority was indicated. Adverse event profiles were similar in the two treatment groups and were mainly non-serious. Treatment with ceftolozane-tazobactam led to better responses than high-dose levofloxacin in patients with complicated lower-urinary-tract infections or pyelonephritis. Cubist Pharmaceuticals.
    Keywords: Medicine
    ISSN: 0140-6736
    E-ISSN: 1474-547X
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  • 5
    Language: English
    In: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 01 February 2017, Vol.64(3), pp.391
    Keywords: Ceftazidime ; Doripenem
    E-ISSN: 1537-6591
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 6
    Language: English
    In: Antimicrobial agents and chemotherapy, June 2016, Vol.60(6), pp.3309-15
    Description: This annex study to a phase 1 study aimed to correlate urinary concentrations and bactericidal titers (UBTs) of BAL30072, a novel siderophore monosulfactam, in healthy subjects in order to evaluate which dosage of BAL30072 should be investigated in a clinical study on complicated urinary tract infection (UTI). Three cohorts of a total of 19 healthy male subjects were included in the add-on study and received the following BAL30072 dosages. The 1st cohort received 1 g once a day (q.d.) intravenously (i.v.) (1 h) on day 1 and 1 g thrice daily (t.i.d.) on day 2, the 2nd cohort received 2 g q.d. i.v. (1 h) on day 1 and 2 g t.i.d. on day 2, and the 3rd cohort received 1 g q.d. i.v. (4-h infusion) on day 8. Urine was collected up to 24 h after drug administration. UBTs were determined for seven Escherichia coli isolates (three wild type [WT], CTX-M-15, TEM-3, TEM-5, NDM-1), two Klebsiella pneumoniae isolates (WT, KPC), one Proteus mirabilis isolate (WT), and two Pseudomonas aeruginosa isolates (WT, VIM-1 plus AmpC). Urine drug concentrations were measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The median urinary excretions of BAL30072 ranged between 38% and 46% (3 cohorts). The median UBTs after i.v. administration of 1 or 2 g q.d. and after 1 or 2 g t.i.d. showed positive UBTs for 24 h after the lowest dosage (1 g q.d.) for 5 of 7 of the Enterobacteriaceae strains and after the higher dosage of 2 g administered i.v. t.i.d. for all strains tested. After i.v. infusion of 1 g over 4 h, positive UBTs were demonstrated for three E. coli strains for up to 12 h, for the K. pneumoniae (KPC) strain for up to 8 h, and for the P. aeruginosa (VIM-1 plus AmpC) strain for up to only 4 h. The minimal bactericidal concentrations (MBCs) of the E. coli (NDM-1) strain and the K. pneumoniae (WT) strain correlated well between broth and urine but did not correlate well for the two P. aeruginosa strains. BAL30072 exhibits positive UBTs for 24 h even after a dosage of 1 g administered i.v. q.d. for 5 of 7 Enterobacteriaceae strains and after 2 g administered i.v. t.i.d. for all strains except one P. aeruginosa strain (50% of the time). In general, the UBTs correlated well with the MICs of the Enterobacteriaceae but were lower for P. aeruginosa The clinical efficacy with a dosage regimen of BAL30072 of 2 g administered i.v. t.i.d. should be evaluated in the treatment of complicated UTI.
    Keywords: Anti-Bacterial Agents -- Therapeutic Use ; Monobactams -- Therapeutic Use ; Thiazoles -- Therapeutic Use ; Urinary Tract Infections -- Drug Therapy
    ISSN: 00664804
    E-ISSN: 1098-6596
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  • 7
    Language: English
    In: World Journal of Urology, Feb, 2012, Vol.30(1), p.1(2)
    Description: Byline: Florian M. E. Wagenlehner (1), Tetsuro Matsumoto (2) Author Affiliation: (1) Clinic for Urology, Pediatric Urology and Andrology, Universitatsklinikum Giessen und Marburg GmbH, Standort Giessen, Justus-Liebig-University Giessen, Rudolf-Buchheim Str. 7, 35392, Giessen, Germany (2) Department of Urology, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan Article History: Registration Date: 19/07/2011 Online Date: 11/08/2011
    Keywords: Humans ; Urinary Tract Infections ; Urology;
    ISSN: 0724-4983
    E-ISSN: 14338726
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  • 8
    Language: English
    In: Clinical Infectious Diseases, Sept 15, 2016, Vol.63(6), p.754(9)
    Description: The global emergence of carbapenem-resistant Enterobacteriaceae highlights the urgent need to reduce carbapenem dependence. The phase 3 RECAPTURE program compared the efficacy and safety of ceftazidime-avibactam and doripenem in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis. Hospitalized adults with suspected or microbiologically confirmed cUTI/acute pyelonephritis were randomized 1:1 to ceftazidime-avibactam 2000 mg/500 mg every 8 hours or doripenem 500 mg every 8 hours (doses adjusted for renal function), with possible oral antibiotic switch after ≥5 days (total treatment duration up to 10 days or 14 days for patients with bacteremia). Of 1033 randomized patients, 393 and 417 treated with ceftazidime-avibactam and doripenem, respectively, were eligible for the primary efficacy analyses; 19.6% had ceftazidime-nonsusceptible baseline pathogens. Noninferiority of ceftazidime-avibactam vs doripenem was demonstrated for the US Food and Drug Administration co-primary endpoints of (1) patient-reported symptomatic resolution at day 5: 276 of 393 (70.2%) vs 276 of 417 (66.2%) patients (difference, 4.0% [95% confidence interval {CI}, -2.39% to 10.42%]); and (2) combined symptomatic resolution/microbiological eradication at test of cure (TOC): 280 of 393 (71.2%) vs 269 of 417 (64.5%) patients (difference, 6.7% [95% CI, .30% to 13.12%]). Microbiological eradication at TOC (European Medicines Agency primary endpoint) occurred in 304 of 393 (77.4%) ceftazidime-avibactam vs 296 of 417 (71.0%) doripenem patients (difference, 6.4% [95% CI, .33% to 12.36%]), demonstrating superiority at the 5% significance level. Both treatments showed similar efficacy against ceftazidime-nonsusceptible pathogens. Ceftazidime-avibactam had a safety profile consistent with that of ceftazidime alone. Ceftazidime-avibactam was highly effective for the empiric treatment of cUTI (including acute pyelonephritis), and may offer an alternative to carbapenems in this setting. Clinical Trials Registration: NCT01595438; NCT01599806.
    Keywords: Urinary Tract Infections – Care and Treatment ; Clinical Trials – Usage ; Ceftazidime – Dosage and Administration ; Avibactam – Dosage and Administration ; Pyelonephritis – Influence
    ISSN: 1058-4838
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  • 9
    In: Clinical Infectious Diseases, 2016, Vol. 63(6), pp.754-762
    Description: There is an urgent need for new strategies to reduce carbapenem consumption. Ceftazidime-avibactam was highly effective for empiric treatment of complicated urinary tract infection, including in patients with ceftazidime-nonsusceptible pathogens, and may offer an alternative to carbapenems in this setting. Background.  The global emergence of carbapenem-resistant Enterobacteriaceae highlights the urgent need to reduce carbapenem dependence. The phase 3 RECAPTURE program compared the efficacy and safety of ceftazidime-avibactam and doripenem in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis. Methods.  Hospitalized adults with suspected or microbiologically confirmed cUTI/acute pyelonephritis were randomized 1:1 to ceftazidime-avibactam 2000 mg/500 mg every 8 hours or doripenem 500 mg every 8 hours (doses adjusted for renal function), with possible oral antibiotic switch after ≥5 days (total treatment duration up to 10 days or 14 days for patients with bacteremia). Results.  Of 1033 randomized patients, 393 and 417 treated with ceftazidime-avibactam and doripenem, respectively, were eligible for the primary efficacy analyses; 19.6% had ceftazidime-nonsusceptible baseline pathogens. Noninferiority of ceftazidime-avibactam vs doripenem was demonstrated for the US Food and Drug Administration co-primary endpoints of (1) patient-reported symptomatic resolution at day 5: 276 of 393 (70.2%) vs 276 of 417 (66.2%) patients (difference, 4.0% [95% confidence interval {CI}, −2.39% to 10.42%]); and (2) combined symptomatic resolution/microbiological eradication at test of cure (TOC): 280 of 393 (71.2%) vs 269 of 417 (64.5%) patients (difference, 6.7% [95% CI, .30% to 13.12%]). Microbiological eradication at TOC (European Medicines Agency primary endpoint) occurred in 304 of 393 (77.4%) ceftazidime-avibactam vs 296 of 417 (71.0%) doripenem patients (difference, 6.4% [95% CI, .33% to 12.36%]), demonstrating superiority at the 5% significance level. Both treatments showed similar efficacy against ceftazidime-nonsusceptible pathogens. Ceftazidime-avibactam had a safety profile consistent with that of ceftazidime alone. Conclusions.  Ceftazidime-avibactam was highly effective for the empiric treatment of cUTI (including acute pyelonephritis), and may offer an alternative to carbapenems in this setting. Clinical Trials Registration.  NCT01595438; NCT01599806.
    Keywords: Ceftazidime - Avibactam ; Complicated Urinary Tract Infection ; Acute Pyelonephritis
    ISSN: 1058-4838
    E-ISSN: 1537-6591
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  • 10
    Article
    Article
    Language: English
    In: Deutsches Arzteblatt international, 01 July 2016, Vol.113(26), pp.460-1
    Keywords: Medicine;
    E-ISSN: 1866-0452
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