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Model-informed drug development for antimicrobials: translational pharmacokinetic-pharmacodynamic modelling of apramycin to facilitate prediction of efficacious dose in complicated urinary tract infections.
J Antimicrob Chemother
January 2025
Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Objectives: The use of mouse models of complicated urinary tract infection (cUTI) has usually been limited to a single timepoint assessment of bacterial burden. Based on longitudinal in vitro and in vivo data, we developed a pharmacokinetic-pharmacodynamic (PKPD) model to assess the efficacy of apramycin, a broad-spectrum aminoglycoside antibiotic, in mouse models of cUTI.
Methods: Two Escherichia coli strains were studied (EN591 and ATCC 700336).
Population pharmacokinetics of apramycin from first-in-human plasma and urine data to support prediction of efficacious dose.
J Antimicrob Chemother
September 2022
Department of Pharmacy, Uppsala University, SE-75123, Uppsala, Sweden.
Article Synopsis
- Apramycin, developed as EBL-1003, shows promise against multidrug-resistant bacteria due to its unique structure, which leads to lower toxicity and cross-resistance issues compared to other aminoglycosides.
- A Phase I trial tested increasing doses of apramycin in healthy volunteers, leading to the development of a four-compartment population pharmacokinetic (PPK) model that accurately describes the drug's behavior in the body.
- The study predicts that a daily dose of 30 mg/kg is effective and supports further Phase II clinical trials based on a high probability of achieving therapeutic targets.
Translational in vitro and in vivo PKPD modelling for apramycin against Gram-negative lung pathogens to facilitate prediction of human efficacious dose in pneumonia.
Clin Microbiol Infect
October 2022
Department of Pharmacy, Uppsala University, Uppsala, Sweden. Electronic address:
Objectives: New drugs and methods to efficiently fight carbapenem-resistant gram-negative pathogens are sorely needed. In this study, we characterized the preclinical pharmacokinetics (PK) and pharmacodynamics of the clinical stage drug candidate apramycin in time kill and mouse lung infection models. Based on in vitro and in vivo data, we developed a mathematical model to predict human efficacy.
View Article and Find Full Text PDFRepurposing the Veterinary Antibiotic Apramycin for Antibacterial and Antibiofilm Activity Against From Cystic Fibrosis Patients.
Front Microbiol
February 2022
Center for Advanced Studies and Technology (CAST), "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.
Objectives: To evaluate the antibacterial, antibiofilm, and antivirulence activities of apramycin, comparatively to tobramycin, against a set of from chronically infected cystic fibrosis (CF) patients.
Methods: The activity of antibiotics against planktonic cells was assessed by performing MIC, MBC, and time-kill assays. The activity against mature biofilms was evaluated, in a microtiter plate, both in terms of dispersion (crystal violet assay) and residual viability (viable cell count).
Clinical Breakpoint of Apramycin to Swine and Its Effect on Ileum Flora.
Int J Mol Sci
January 2022
National Reference Laboratory of Veterinary Drug Residues and MOA Key Laboratory for Detection of Veterinary Drug Residues, Huazhong Agricultural University, Wuhan 430070, China.
The purpose of this study was to establish the clinical breakpoint (CBP) of apramycin (APR) against in swine and evaluate its effect on intestinal microbiota. The CBP was established based on three cutoff values of wild-type cutoff value (CO), pharmacokinetic-pharmadynamic (PK/PD) cutoff value (CO) and clinical cutoff value (CO). The effect of the optimized dose regimen based on ex vivo PK/PD study.
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