https://scholars.lib.ntu.edu.tw/handle/123456789/566368
DC 欄位 | 值 | 語言 |
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dc.contributor.author | Bradley J.S. | en_US |
dc.contributor.author | Roilides E. | en_US |
dc.contributor.author | Broadhurst H. | en_US |
dc.contributor.author | Cheng K. | en_US |
dc.contributor.author | LI-MIN HUANG | en_US |
dc.contributor.author | Mascasullo V. | en_US |
dc.contributor.author | Newell P. | en_US |
dc.contributor.author | Stone G.G. | en_US |
dc.contributor.author | Tawadrous M. | en_US |
dc.contributor.author | Wajsbrot D. | en_US |
dc.contributor.author | Yates K. | en_US |
dc.contributor.author | Gardner A. | en_US |
dc.creator | Bradley J.S.;Roilides E.;Broadhurst H.;Cheng K.;Li-Min Huang;Mascasullo V.;Newell P.;Stone G.G.;Tawadrous M.;Wajsbrot D.;Yates K.;Gardner A. | - |
dc.date.accessioned | 2021-06-24T07:16:08Z | - |
dc.date.available | 2021-06-24T07:16:08Z | - |
dc.date.issued | 2019 | - |
dc.identifier.issn | 0891-3668 | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85071352827&doi=10.1097%2fINF.0000000000002395&partnerID=40&md5=8aad041ab6693945803b429e38dcd559 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/566368 | - |
dc.description.abstract | Background: Ceftazidime-avibactam is effective and well tolerated in adults with complicated urinary tract infection (cUTI), but has not been evaluated in children with cUTI. Methods: This single-blind, multicenter, active-controlled, phase 2 study (NCT02497781) randomized children ?3 months to <18 years with cUTI (3:1) to receive intravenous (IV) ceftazidime-avibactam or cefepime for ?72 hours, with subsequent optional oral switch. Total treatment duration was 7-14 days. Primary objective was assessment of safety. Secondary objectives included descriptive efficacy and pharmacokinetics. A blinded observer determined adverse event (AE) causality and clinical outcomes up to the late follow-up visit (20-36 days after the last dose of IV/oral therapy). Results: In total, 95 children received ?1 dose of IV study drug (ceftazidime-avibactam, n = 67; cefepime, n = 28). The predominant baseline Gram-negative uropathogen was Escherichia coli (92.2%). AEs occurred in 53.7% and 53.6% patients in the ceftazidime-avibactam and cefepime groups, respectively. Serious AEs occurred in 11.9% (ceftazidime-avibactam) and 7.1% (cefepime) patients. One serious AE (ceftazidime-avibactam group) was considered drug related. In the microbiologic intent-to-treat analysis set, favorable clinical response rates >95% were observed for both groups at end-of-IV and remained 88.9% (ceftazidime-avibactam) and 82.6% (cefepime) at test-of-cure. Favorable per-patient microbiologic response at test-of-cure was 79.6% (ceftazidime-avibactam) and 60.9% (cefepime). Conclusions: Ceftazidime-avibactam was well tolerated in children with cUTI, with a safety profile consistent with that of adults with cUTI and of ceftazidime alone, and appeared effective in children with cUTI due to Gram-negative pathogens. ? 2019 Wolters Kluwer Health, Inc. All rights reserved. | - |
dc.publisher | Lippincott Williams and Wilkins | - |
dc.relation.ispartof | Pediatric Infectious Disease Journal | - |
dc.subject | cefepime; ceftazidime-avibactam; complicated urinary tract infection; pediatric; phase 2 | - |
dc.subject.classification | [SDGs]SDG3 | - |
dc.subject.other | avibactam plus ceftazidime; cefepime; antiinfective agent; avibactam, ceftazidime drug combination; azabicyclo derivative; ceftazidime; abdominal pain; acute pyelonephritis; adolescent; Article; child; clinical outcome; constipation; controlled study; coughing; cystitis; diarrhea; drug efficacy; drug safety; drug tolerability; Escherichia coli; female; fever; gastroenteritis; gastrointestinal disease; human; major clinical study; male; multicenter study; nausea; nephrolithiasis; neurologic disease; phase 2 clinical trial; priority journal; randomized controlled trial; rash; rhinopharyngitis; single blind procedure; treatment duration; treatment response; upper respiratory tract infection; urinary tract infection; vomiting; vulvitis; clinical trial; complication; drug combination; drug effect; infant; intravenous drug administration; microbiology; multidrug resistance; preschool child; urinary tract infection; Administration, Intravenous; Adolescent; Anti-Bacterial Agents; Azabicyclo Compounds; Ceftazidime; Child; Child, Preschool; Drug Combinations; Drug Resistance, Multiple, Bacterial; Escherichia coli; Female; Humans; Infant; Male; Single-Blind Method; Urinary Tract Infections | - |
dc.title | Safety and Efficacy of Ceftazidime-Avibactam in the Treatment of Children ?3 Months to <18 Years with Complicated Urinary Tract Infection: Results from a Phase 2 Randomized, Controlled Trial | en_US |
dc.type | journal article | en |
dc.identifier.doi | 10.1097/INF.0000000000002395 | - |
dc.identifier.pmid | 31335570 | - |
dc.identifier.scopus | 2-s2.0-85071352827 | - |
dc.relation.pages | 920-928 | - |
dc.relation.journalvolume | 38 | - |
dc.relation.journalissue | 9 | - |
item.openairecristype | http://purl.org/coar/resource_type/c_6501 | - |
item.grantfulltext | none | - |
item.fulltext | no fulltext | - |
item.openairetype | journal article | - |
item.cerifentitytype | Publications | - |
crisitem.author.dept | Pediatrics | - |
crisitem.author.dept | Epidemiology and Preventive Medicine | - |
crisitem.author.dept | National Taiwan University Children's Hospital | - |
crisitem.author.dept | Pediatrics-NTUH | - |
crisitem.author.orcid | 0000-0002-9291-260X | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | College of Public Health | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
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