{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T03:06:15Z","timestamp":1791083175817,"version":"4.1.0"},"reference-count":59,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T00:00:00Z","timestamp":1694563200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["NCT01499290"],"award-info":[{"award-number":["NCT01499290"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["NCT01726023"],"award-info":[{"award-number":["NCT01726023"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["NCT01644643"],"award-info":[{"award-number":["NCT01644643"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["NCT01595438"],"award-info":[{"award-number":["NCT01595438"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","award":["NCT01808092"],"award-info":[{"award-number":["NCT01808092"]}],"id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>This post hoc pooled analysis evaluated clinical and microbiological outcomes and safety in patients with infections caused by \u03b2-lactamase-producing Gram-negative pathogens across five Phase 3, randomized, controlled, multicentre trials of ceftazidime\/avibactam in adults with complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI)\/pyelonephritis and nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In each trial, RECLAIM\/RECLAIM 3 (cIAI), REPRISE (cIAI\/cUTI), RECAPTURE (cUTI) and REPROVE (NP, including VAP) patients were randomized 1:1 to IV ceftazidime\/avibactam (plus metronidazole for patients with cIAI) or comparators (carbapenems in &amp;gt;97% patients) for 5\u201321 days. Clinical and microbiological responses at the test-of-cure visit were assessed for patients with ESBLs, and\/or plasmidic and\/or overexpression of chromosomal AmpC, and\/or serine carbapenemases without MBLs identified in baseline Gram-negative isolates by phenotypic screening and molecular characterization in the pooled microbiological modified ITT (mMITT) population.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In total, 813 patients (ceftazidime\/avibactam, n\u200a=\u200a389; comparator, n\u200a=\u200a424) had \u22651 \u03b2-lactamase-producing baseline pathogen identified, amongst whom 792 patients (ceftazidime\/avibactam, n\u200a=\u200a379; comparator, n\u200a=\u200a413) had no MBLs. The most frequent \u03b2-lactamase-producing pathogens across treatment groups were Escherichia coli (n\u200a=\u200a381), Klebsiella pneumoniae (n\u200a=\u200a261) and Pseudomonas aeruginosa (n\u200a=\u200a53). Clinical cure rates in the pooled non-MBL \u03b2-lactamase-producing mMITT population were 88.1% (334\/379) for ceftazidime\/avibactam and 88.1% (364\/413) for comparators; favourable microbiological response rates were 76.5% (290\/379) and 68.8% (284\/413), respectively. The safety profile of ceftazidime\/avibactam was consistent with previous observations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This analysis provides supportive evidence of the efficacy and safety of ceftazidime\/avibactam in patients with infections caused by ESBLs, AmpC and serine carbapenemase-producing Gram-negative pathogens.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>NCT01499290; NCT01726023; NCT01644643; NCT01595438\/NCT01599806; NCT01808092.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkad280","type":"journal-article","created":{"date-parts":[[2023,9,13]],"date-time":"2023-09-13T07:26:33Z","timestamp":1694589993000},"page":"2672-2682","source":"Crossref","is-referenced-by-count":28,"title":["Efficacy and safety of ceftazidime\/avibactam in patients with infections caused by \u03b2-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme"],"prefix":"10.1093","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8643-2167","authenticated-orcid":false,"given":"Antoni","family":"Torres","sequence":"first","affiliation":[{"name":"Servei de Pneumologia, Hospital Clinic, University of Barcelona , Villarroel 170 , 08036, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Wible","sequence":"additional","affiliation":[{"name":"Pfizer , Collegeville, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6815-2647","authenticated-orcid":false,"given":"Margaret","family":"Tawadrous","sequence":"additional","affiliation":[{"name":"Hospital Business Unit, Pfizer , Groton, CT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paurus","family":"Irani","sequence":"additional","affiliation":[{"name":"Hospital Business Unit, Pfizer, Tadworth , Surrey , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory G","family":"Stone","sequence":"additional","affiliation":[{"name":"Hospital Business Unit, Pfizer , Groton, CT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8359-9909","authenticated-orcid":false,"given":"Alvaro","family":"Quintana","sequence":"additional","affiliation":[{"name":"Hospital Business Unit, Pfizer , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitri","family":"Debabov","sequence":"additional","affiliation":[{"name":"Non-clinical Development Microbiology, AbbVie , Irvine, CA , 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