{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T07:57:00Z","timestamp":1791100620469,"version":"4.1.0"},"reference-count":20,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2011,3,1]],"date-time":"2011-03-01T00:00:00Z","timestamp":1298937600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Aerosol Medicine and Pulmonary Drug Delivery"],"published-print":{"date-parts":[[2011,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>BAY41-6551, a drug\u2013device combination in development for adjunctive treatment of Gram-negative pneumonia in intubated and mechanically ventilated patients, consists of amikacin formulated for inhalation coupled with the Pulmonary Drug Delivery System (PDDS) Clinical aerosol delivery platform. Given the predominantly renal clearance of aminoglycosides, understanding systemic amikacin exposure and safety during administration of BAY41-6551 to patients with acute renal failure (ARF) is clinically important.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Seven mechanically ventilated patients with Gram-negative pneumonia and ARF receiving continuous veno-venous hemodiafiltration (CVVHDF) were treated with multiple administrations of BAY41-6551 400\u2009mg amikacin twice daily using the PDDS Clinical on-ventilator device [in addition to standard intravenous (i.v.) antimicrobial therapy]. CVVHDF parameters were recorded and a PK analysis was performed using serum, urine, and bronchoalveolar lavage fluid samples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Maximum serum amikacin concentration [median 1.93 (range: 0.63\u20133.99) mg\/L] and area under the concentration\u2013time curve from zero to 12\u2009h on day 3 [median 19.32 (range 6.32\u201336.87) mg\u2009\u00b7\u2009h\/L] were elevated compared with mechanically ventilated patients with normal renal function; however, serum amikacin trough concentrations were within accepted safety limits. The median amikacin concentration in epithelial lining fluid [887 (range: 406\u201312,819) mg\/L] was similar to that reported previously in mechanically ventilated patients with normal renal function. BAY41-6551 demonstrated acceptable safety and tolerability with most adverse events (AEs) as expected for the patient population. One serious AE of bronchospasm was attributed to the study medication; no reported AEs were related to the PDDS Clinical device.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>CVVHDF appears to provide adequate clearance of systemically absorbed amikacin in mechanically ventilated patients with ARF, suggesting that dose adjustments for BAY41-6551 are probably not necessary for this patient population. Nonetheless, the standard precautionary measures for critically ill patients receiving i.v. amikacin should be followed for patients with ARF who are treated with BAY41-6551.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jamp.2010.0860","type":"journal-article","created":{"date-parts":[[2011,3,2]],"date-time":"2011-03-02T20:41:07Z","timestamp":1299098467000},"page":"183-190","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":35,"title":["Pharmacokinetics and Tolerability of Amikacin Administered as BAY41-6551 Aerosol in Mechanically Ventilated Patients with Gram-Negative Pneumonia and Acute Renal Failure"],"prefix":"10.1177","volume":"24","author":[{"given":"Charles-Edouard","family":"Luyt","sequence":"first","affiliation":[{"name":"H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Eldon","sequence":"additional","affiliation":[{"name":"Nektar Therapeutics"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heino","family":"Stass","sequence":"additional","affiliation":[{"name":"Bayer Schering Pharma AG","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Gribben","sequence":"additional","affiliation":[{"name":"Talima Therapeutics"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Corkery","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceutical Corp."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Chastre","sequence":"additional","affiliation":[{"name":"H\u00f4pital Piti\u00e9-Salp\u00eatri\u00e8re","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2011,3,1]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/432803"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200405-644ST"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1586\/17434440.5.1.9"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1086\/514620"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2001.00377.x"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.4187\/respcare.07520866"},{"key":"e_1_3_3_8_2","first-page":"517","volume-title":"American Thoracic Society International Conference 2008","author":"Corkery K","unstructured":"Corkery K, , Gribben D, , Fink J, , Eldon M, , Niederman M. Evidence of high amikacin lung deposition in mechanically ventilated patients (MVP) with pneumonia, healthy subjects (HS) dosed using NKTR-061. American Thoracic Society International Conference 2008, May 16\u201321, 2008, Toronto, CanadaPoster517."},{"key":"e_1_3_3_9_2","first-page":"A135","volume-title":"28th International Symposium on Intensive Care and Emergency Medicine","author":"Eldon M","unstructured":"Eldon M, , Corkery K, , Gribben D, , Fink J, , Niederman M. NKTR-061 (inhaled amikacin) delivers high lung doses in mechanically ventilated patients (MVP) with pneumonia, healthy subjects (HS) 28th International Symposium on Intensive Care and Emergency Medicine, March 18\u201321, 2008, Brussels, BelgiumPosterA135."},{"key":"e_1_3_3_10_2","first-page":"720","volume-title":"American Thoracic Society International Conference 2007","author":"Chastre J","unstructured":"Chastre J, , Sanchez M, , Corkery K, , Fink JB, , Luyt CE, , Niederman MS. NKTR-061 achieves safe serum concentrations after repeat dosing in intubated, mechanically ventilated patients with Gram-negative pneumonia: a pharmacokinetic study. American Thoracic Society International Conference 2007, May 18\u201323, 2007, San Francisco, CA, USAPoster720."},{"key":"e_1_3_3_11_2","first-page":"718","volume-title":"American Thoracic Society International Conference 2007","author":"Niederman MS","unstructured":"Niederman MS, , Chastre J, , Corkery K, , Marcantonio A, , Fink JB, , Luyt CE, , Sanchez M. The Amikacin Study Group: NKTR-061 (inhaled amikacin) reduces intravenous antibiotic use in intubated mechanically ventilated patients during treatment of Gram-negative pneumonia. American Thoracic Society International Conference 2007, May 18\u201323, 2007, San Francisco, CA, USAPoster718."},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.39.1.264"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1159\/000231986"},{"key":"e_1_3_3_14_2","volume-title":"American Thoracic Society International Conference 2004","author":"Mercier E","unstructured":"Mercier E, , Valat C, , Fishman RS, , Fink JB, , Smith N, , Gibbons K, , Diot P, , Dequin PF. Aerosol delivery of amikacin by three nebulizers of varying efficiency in patients on mechanical ventilators. American Thoracic Society International Conference 2004, May 21\u201326, 2004, Orlando, FL, USA. Poster presentation."},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1186\/cc8206"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm-conference.2009.179.1_MeetingAbstracts.A2878"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/44.5.1129"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1570-0232(03)00492-6"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007691-199704000-00017"},{"key":"e_1_3_3_20_2","unstructured":"EUCAST: Aminoglycosides\u2014EUCAST clinical MIC breakpoints 2009-06-15 (v 1.5) http:\/\/www.srga.org\/eucastwt\/MICTAB\/MICaminoglycosides.html. 2010 June 3."},{"issue":"1","key":"e_1_3_3_21_2","first-page":"i1","article-title":"British Thoracic Society Bronchoscopy Guidelines Committee: British Thoracic Society guidelines on diagnostic flexible bronchoscopy","volume":"56","year":"2001","unstructured":"British Thoracic Society Bronchoscopy Guidelines Committee: British Thoracic Society guidelines on diagnostic flexible bronchoscopy. 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