{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T13:02:24Z","timestamp":1770037344955,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:00:00Z","timestamp":1760832000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T00:00:00Z","timestamp":1760832000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Multidrug\u2013resistant Enterobacteriaceae are a primary cause of complicated urinary tract infections (cUTIs) worldwide. This study compared pharmacokinetic (PK) parameters of plazomicin among Indian versus non\u2013India participants. This was a post hoc analysis of PK data from the Phase 2 study (ACHN\u2013490\u2010002), a multicenter, double\u2013blind, randomized, comparator\u2013controlled study. Eligible participants (aged 18\u201085 years, body weight \u2264100\u00a0kg) with documented\/suspected cUTI or acute pyelonephritis received either 10 or 15\u00a0mg\/kg plazomicin. Among 91 participants, 70 were non\u2013Indian and 21 were Indian. For the 15\u00a0mg\/kg dose, plazomicin demonstrated a higher area under the plasma time\u2013concentration curve from time 0 to 24 h (AUC\n                    <jats:sub>0\u201024<\/jats:sub>\n                    ) and maximum concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) compared to the 10\u00a0mg\/kg dose, which showed greater variability. At the 10\u00a0mg\/kg dose, Indian participants had a mean AUC\n                    <jats:sub>0\u201024<\/jats:sub>\n                    of 163.0 mg\u2022h\/L, while non\u2013Indian participants had a mean AUC\n                    <jats:sub>0\u201024<\/jats:sub>\n                    of 185.0 mg\u2022h\/L. The estimated mean plazomicin AUC\n                    <jats:sub>0\u201024<\/jats:sub>\n                    values were comparable between Indian and non\u2013Indian participants. The mean C\n                    <jats:sub>max<\/jats:sub>\n                    for Indian participants was 17.2 mg\u2022h\/L, and for non\u2013Indian participants it was 15.7 mg\u2022h\/L. Dose\u2013normalized AUC\n                    <jats:sub>0\u201024<\/jats:sub>\n                    and C\n                    <jats:sub>max<\/jats:sub>\n                    point estimates were 110% and 103%, respectively. This showed comparable plazomicin exposure in Indian and non\u2013Indian patients.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1616","type":"journal-article","created":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T14:42:19Z","timestamp":1760884939000},"page":"903-910","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Plazomicin Pharmacokinetics in Indian Complicated Urinary Tract Infections Patients: A Subgroup Analysis from a Phase 2 Study"],"prefix":"10.1002","volume":"14","author":[{"given":"Vaishali","family":"Gupte","sequence":"first","affiliation":[{"name":"Medical Affairs Cipla Ltd. Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandesh","family":"Sawant","sequence":"additional","affiliation":[{"name":"Medical Affairs Cipla Ltd. Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Senthilnathan","family":"Mohanasundaram","sequence":"additional","affiliation":[{"name":"Medical Affairs Cipla Ltd. Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rohit","family":"Malabade","sequence":"additional","affiliation":[{"name":"Medical Affairs Cipla Ltd. Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anup","family":"Warrier","sequence":"additional","affiliation":[{"name":"Infectious Diseases and Infection Control Aster Medcity  Kochi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. N.","family":"Sivakumar","sequence":"additional","affiliation":[{"name":"Institute of Critical Care Medicine Royal Care Super Specialty Hospital  Coimbatore India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yogendra Pal","family":"Singh","sequence":"additional","affiliation":[{"name":"Department of Critical Care Medicine Max Super Specialty Hospital  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pradeep","family":"Bhattacharya","sequence":"additional","affiliation":[{"name":"Critical Care Trauma and Emergency Centre Rajendra Institute of Medical Sciences  Ranchi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajesh","family":"Chawla","sequence":"additional","affiliation":[{"name":"Respiratory Medicine Critical Care and Sleep Medicine Apollo Hospitals  New Delhi India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaideep","family":"Gogtay","sequence":"additional","affiliation":[{"name":"Medical Affairs Cipla Ltd. Mumbai India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,19]]},"reference":[{"issue":"3","key":"e_1_2_10_2_1","first-page":"iii25","article-title":"Complicated urinary tract infections: practical solutions for the treatment of multiresistant Gram\u2010negative bacteria","volume":"65","author":"Pallett A","year":"2010","journal-title":"J Antimicrob Chemother"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2024.1387497"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/00325481.2017.1246055"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofv050"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mib.2022.102204"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1101\/cshperspect.a027029"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/phar.2203"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00624-11"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.653"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.648"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02329-18"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofy210.1231"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01128-18"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01989-17"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1801467"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1807634"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/aac.02074-21"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1616","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1616","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1616","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T12:37:54Z","timestamp":1769863074000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1616"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,19]]},"references-count":17,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/cpdd.1616"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1616","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,19]]},"assertion":[{"value":"2025-01-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}