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Clinical Therapeutics

Pharmacokinetic and Pharmacodynamic Profiling of Minocycline for Injection following a Single Infusion in Critically Ill Adults in a Phase IV Open-Label Multicenter Study (ACUMIN)

Thomas P. Lodise, Scott Van Wart, Zoe M. Sund, Adam M. Bressler, Akram Khan, Amy T. Makley, Yasir Hamad, Robert A. Salata, Fernanda P. Silveira, Matthew D. Sims, Badih A. Kabchi, Mohamed A. Saad, Carrie Brown, Randolph E. Oler Jr., Vance Fowler Jr., Richard G. Wunderink
Thomas P. Lodise
aAlbany College of Pharmacy and Health Sciences, Albany, New York, USA
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Scott Van Wart
bEnhanced Pharmacodynamics, LLC, Buffalo, New York, USA
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Zoe M. Sund
cDuke University, Durham, North Carolina, USA
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Adam M. Bressler
dInfectious Disease Specialists of Atlanta, Decatur, Georgia, USA
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Akram Khan
eOregon Health and Science University, Portland, Oregon, USA
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Amy T. Makley
fDepartment of Surgery, University of Cincinnati, Cincinnati, Ohio, USA
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Yasir Hamad
gDepartment of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA
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Robert A. Salata
hDivision of Infectious Diseases and HIV Medicine, Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, Ohio, USA
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Fernanda P. Silveira
iDepartment of Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA
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Matthew D. Sims
jBeaumont Hospital, Royal Oak, Michigan, USA
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Badih A. Kabchi
kBrody School of Medicine, East Carolina University, Greenville, North Carolina, USA
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Mohamed A. Saad
lUniversity of Louisville, Louisville, Kentucky, USA
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Carrie Brown
mEmmes, Rockville, Maryland, USA
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Randolph E. Oler Jr.
mEmmes, Rockville, Maryland, USA
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Vance Fowler Jr.
nDivision of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA
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Richard G. Wunderink
oNorthwestern University, Chicago, Illinois, USA
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DOI: 10.1128/AAC.01809-20
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ABSTRACT

Intravenous (i.v.) minocycline is increasingly used to treat infections caused by multidrug-resistant (MDR) Acinetobacter baumannii. Despite its being approved nearly 50 years ago, published information on its pharmacokinetic (PK) profile is limited. This multicenter study examined the PK and probability of pharmacokinetic-pharmacodynamic (PK-PD) target attainment profile of i.v. minocycline in critically ill patients, with suspected or documented infection with Gram-negative bacteria. The PK study population included 55 patients who received a single 200-mg i.v. dose of minocycline. Plasma PK samples were collected predose and 1, 4, 12, 24, 36, and 48 h after initiation of minocycline. Total and unbound minocycline concentrations were determined at each time point. Probabilities of achieving the PK-PD targets associated with stasis and 1-log killing (free area under the curve above the MIC [fAUC:MIC] of 12 and 18, respectively) in an immunocompetent animal pneumonia infection model of A. baumannii were evaluated. A two-compartment population PK model with zero-order i.v. input and first-order elimination, which estimated a constant fraction unbound (fub) for minocycline, best characterized the total and unbound plasma minocycline concentration-time data. The only two covariates retained in the final PK model were body surface area (associated with central volume of distribution) and albumin (associated with fub). In the PK-PD probability of target attainment analyses, minocycline 200 mg i.v. every 12 h (Q12H) was predicted to result in a suboptimal PK-PD profile for patients with A. baumannii infections with MIC values of >1 mg/liter. Like all PK-PD profiling studies of this nature, these findings need clinical confirmation.

FOOTNOTES

    • Received 20 August 2020.
    • Returned for modification 24 September 2020.
    • Accepted 24 October 2020.
    • Accepted manuscript posted online 9 November 2020.
  • Supplemental material is available online only.

  • Copyright © 2021 American Society for Microbiology.

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Pharmacokinetic and Pharmacodynamic Profiling of Minocycline for Injection following a Single Infusion in Critically Ill Adults in a Phase IV Open-Label Multicenter Study (ACUMIN)
Thomas P. Lodise, Scott Van Wart, Zoe M. Sund, Adam M. Bressler, Akram Khan, Amy T. Makley, Yasir Hamad, Robert A. Salata, Fernanda P. Silveira, Matthew D. Sims, Badih A. Kabchi, Mohamed A. Saad, Carrie Brown, Randolph E. Oler Jr., Vance Fowler Jr., Richard G. Wunderink
Antimicrobial Agents and Chemotherapy Feb 2021, 65 (3) e01809-20; DOI: 10.1128/AAC.01809-20

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Pharmacokinetic and Pharmacodynamic Profiling of Minocycline for Injection following a Single Infusion in Critically Ill Adults in a Phase IV Open-Label Multicenter Study (ACUMIN)
Thomas P. Lodise, Scott Van Wart, Zoe M. Sund, Adam M. Bressler, Akram Khan, Amy T. Makley, Yasir Hamad, Robert A. Salata, Fernanda P. Silveira, Matthew D. Sims, Badih A. Kabchi, Mohamed A. Saad, Carrie Brown, Randolph E. Oler Jr., Vance Fowler Jr., Richard G. Wunderink
Antimicrobial Agents and Chemotherapy Feb 2021, 65 (3) e01809-20; DOI: 10.1128/AAC.01809-20
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KEYWORDS

Acinetobacter
minocycline
pharmacodynamics
pharmacokinetics
population pharmacokinetics

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