{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,22]],"date-time":"2026-04-22T02:16:00Z","timestamp":1776824160182,"version":"3.51.2"},"reference-count":47,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T00:00:00Z","timestamp":1734393600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Guideline-based therapy (GBT) for Mycobacterium abscessus (Mab) lung disease achieves sputum culture conversion (SCC) rates of 35%. This poor GBT efficacy is mirrored in the hollow fiber system model of Mab (HFS-Mab). While imipenem is part of GBT, its biologic effect, with or without \u03b2-lactamase inhibitors, is unproven.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We performed imipenem-relebactam minimum inhibitory concentration (MIC) in 122 Mab isolates, and an exposure-response study in the HFS-Mab using human intrapulmonary pharmacokinetics. The percentage of time that concentration persisted above the MIC (TMIC), mediating maximal effect in the HFS-Mab, was used as the exposure target for dose finding in a Monte Carlo experiment including 10 000 virtual patients. For real-world evidence, we performed a patient, intervention (imipenem), comparison (no \u03b2-lactam), and outcome (SCC) (PICO) analysis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Imipenem killed 1.32 log10 colony-forming units\/mL below the day 0 level in HFS-Mab. The average target exposure for imipenem was a TMIC of 47.9% (SD, 9.77%). Infusion of 1 g every 6\u2005hours achieved the target in &amp;gt;90% of virtual patients in Monte Carlo experiments. The pharmacokinetic-pharmacodynamic MIC break point was 1\u2005mg\/L. In PICO analyses, the median time to SCC was 470 days in comparators, 311 days for imipenem added on to a failing regimen, and 37 days in newly treated patients (P = .049). The odds ratio for SCC when imipenem was part of the initial regimen, versus comparators, was 12.5 (95% confidence interval, 1.47\u00ad\u201384.55). No patients receiving imipenem experienced treatment-limiting adverse events, compared with 2 of 7 comparators (P = .046). Middlebrook 7H9 broth MIC distribution, read at 24\u2005hours, was better correlated with patient responses than cation-adjusted Mueller-Hinton broth.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Imipenem demonstrated biologic effect in the HFS-Mab and in patients. Imipenem-relebactam doses of 1\u2005g every 6\u2005hours are recommended.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae601","type":"journal-article","created":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T09:52:52Z","timestamp":1734429172000},"page":"1521-1531","source":"Crossref","is-referenced-by-count":11,"title":["Imipenem Pharmacokinetics\/Pharmacodynamics in Preclinical Hollow Fiber Model, Dose Finding in Virtual Patients, and Clinical Evidence of Efficacy for <i>Mycobacterium abscessus<\/i> Lung Disease"],"prefix":"10.1093","volume":"231","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4601-5673","authenticated-orcid":false,"given":"Sanjay","family":"Singh","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, School of Medicine, University of Texas at Tyler , Tyler, Texas ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7592-8012","authenticated-orcid":false,"given":"Tawanda","family":"Gumbo","sequence":"additional","affiliation":[{"name":"Mathematical Modeling and AI Department, Praedicare , Dallas, Texas ,","place":["USA"]},{"name":"Hollow Fiber System & Experimental Therapeutics Laboratories, Wet Lab Systems, Praedicare , Dallas, Texas ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3406-366X","authenticated-orcid":false,"given":"Jann-Yuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, National Taiwan University Hospital , Taipei ,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gunavanthi D","family":"Boorgula","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, School of Medicine, University of Texas at Tyler , Tyler, Texas ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2742-1556","authenticated-orcid":false,"given":"Andrew","family":"Burke","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, The Prince Charles Hospital Rode Rd Chermside , Queensland, Brisbane ,","place":["Australia"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hung-Ling","family":"Huang","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Kaohsiung Medical University Hospital , Kaohsuing ,","place":["Taiwan"]},{"name":"Department of Internal Medicine, Kaohsiung Medical University Hospital , Kaohsuing ,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela J","family":"McShane","sequence":"additional","affiliation":[{"name":"Department of Medicine, Section of Pulmonary and Critical Care, School of Medicine, University of Texas at Tyler , Tyler, Texas ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rodolfo","family":"Amaro-Galvez","sequence":"additional","affiliation":[{"name":"Department of Medicine, Section of Pulmonary and Critical Care, School of Medicine, University of Texas at Tyler , Tyler, Texas ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane E","family":"Gross","sequence":"additional","affiliation":[{"name":"Department of Pediatric Pulmonary Medicine, National Jewish Hospital , Denver, Colorado ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Santosh","family":"Aryal","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences and Health Outcomes, The Ben and Maytee Fisch College of Pharmacy, University of Texas at Tyler , Tyler, Texas ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott 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