ArticleAntimicrobial agents and chemotherapy2020
Population Pharmacokinetic Analyses for Omadacycline Using Phase 1 and 3 Data.
Article in Antimicrobial agents and chemotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The trial behind it
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Who cites it
20 citing papers in PubMed.
- Assessment of pharmacokinetics-pharmacodynamics to support omadacycline dosing regimens for the treatment of patients with acute bacterial skin and skin structure infections.Antimicrobial agents and chemotherapy · 2024Trial
- Pharmacokinetic-Pharmacodynamic Target Attainment Analyses Evaluating Omadacycline Dosing Regimens for the Treatment of Patients with Community-Acquired Bacterial Pneumonia Arising from Streptococcus pneumoniae and Haemophilus influenzae.Antimicrobial agents and chemotherapy · 2023Trial
- Pulmonary Pharmacokinetics/Pharmacodynamics of Commonly Used Antibiotics in the Treatment of Community-Acquired Pneumonia.European journal of drug metabolism and pharmacokinetics · 2026Review
- Methodologies for Population Pharmacokinetic Modeling of Target-Site Drug Exposure: A Narrative Review of Current Strategies.Clinical pharmacokinetics · 2026Review
- Novel regimens for treatment ofbioRxiv : the preprint server for biology · 2026Article
- Omadacycline Pharmacokinetics: Characteristics, Contributing Factors, and Clinical Significance.Drugs in R&D · 2025Review
- Omadacycline pharmacokinetics/pharmacodynamics and efficacy against multidrug-resistantAntimicrobial agents and chemotherapy · 2024Article
- Bidirectional Interaction between Tetracyclines and Gut Microbiome.Antibiotics (Basel, Switzerland) · 2023Review
- Evaluation of the Impact of Comorbidities on Omadacycline Pharmacokinetics.Antimicrobial agents and chemotherapy · 2023Article
- All Roads Lead to Rome: Enhancing the Probability of Target Attainment with Different Pharmacokinetic/Pharmacodynamic Modelling Approaches.Antibiotics (Basel, Switzerland) · 2023Review
- Omadacycline Pharmacokinetics: Influence of Mortality Risk Score among Patients with Community-Acquired Bacterial Pneumonia.Antimicrobial agents and chemotherapy · 2023Article
- Omadacycline efficacy in the hollow fibre system model of pulmonary Mycobacterium avium complex and potency at clinically attainable doses.The Journal of antimicrobial chemotherapy · 2022Article
- Omadacycline pharmacokinetics and soft-tissue penetration in diabetic patients with wound infections and healthy volunteers using in vivo microdialysis.The Journal of antimicrobial chemotherapy · 2022Article
- Omadacycline Oral Dosing and Pharmacokinetics in Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infection.Clinical drug investigation · 2022Review
- Pharmacokinetics, Safety and Pharmacokinetics/Pharmacodynamics Analysis of Omadacycline in Chinese Healthy Subjects.Frontiers in pharmacology · 2022Article
- Penetration of Antibacterial Agents into Pulmonary Epithelial Lining Fluid: An Update.Clinical pharmacokinetics · 2022Review
- Use of oral tetracyclines in the treatment of adult outpatients with skin and skin structure infections: Focus on doxycycline, minocycline, and omadacycline.Pharmacotherapy · 2021Review
- Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections.The Journal of antimicrobial chemotherapy · 2021Article
- Use of Oral Tetracyclines in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia: A Literature Review on the Often-Overlooked Antibiotic Class.Antibiotics (Basel, Switzerland) · 2020Review
- Omadacycline: a novel aminomethylcycline.Infection and drug resistance · 2019Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Omadacycline, a novel aminomethylcycline antibiotic with activity against Gram-positive and -negative organisms, including tetracycline-resistant pathogens, received FDA approval in October 2018 for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). A previously developed population pharmacokinetic (PK) model based on phase 1 intravenous and oral PK data was refined using data from infected patients. Data from 10 phase 1 studies used to develop the previous model were pooled with data from three additional phase 1 studies, a phase 1b uncomplicated urinary tract infection study, one phase 3 CABP study, and two phase 3 ABSSSI studies. The final population PK model was a three-compartment model with first-order absorption using transit compartments to account for absorption delay following oral dosing and first-order elimination. Epithelial lining fluid (ELF) concentrations were modeled as a subcompartment of the first peripheral compartment. A food effect on oral bioavailability was included in the model. Sex was the only significant covariate identified, with 15.6% lower clearance for females than males. Goodness-of-fit diagnostics indicated a precise and unbiased fit to the data. The final model, which was robust in its ability to predict plasma and ELF exposures following omadacycline administration, was also able to predict the central tendency and variability in concentration-time profiles using an external phase 3 ABSSSI data set. A population PK model, which described omadacycline PK in healthy subjects and infected patients, was developed and subsequently used to support pharmacokinetic-pharmacodynamic (PK-PD) and PK-PD target attainment assessments.
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