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

Author:

Bhavnani Sujata M.1ORCID,Hammel Jeffrey P.1,Lakota Elizabeth A.1,Trang Michael1ORCID,Bader Justin C.1,Bulik Catharine C.1,VanScoy Brian D.1ORCID,Rubino Christopher M.1ORCID,Huband Michael D.2ORCID,Friedrich Lawrence3,Steenbergen Judith N.3,Ambrose Paul G.1ORCID

Affiliation:

1. Institute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA

2. JMI Laboratories, North Liberty, Iowa, USA

3. Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA

Abstract

Omadacycline, a novel aminomethylcycline with in vitro activity against Gram-positive and -negative organisms, including Streptococcus pneumoniae and Haemophilus influenzae , is approved in the United States to treat patients with community-acquired bacterial pneumonia (CABP). Using nonclinical pharmacokinetic-pharmacodynamic (PK-PD) targets for efficacy and in vitro surveillance data for omadacycline against S. pneumoniae and H. influenzae , and a population pharmacokinetic model, PK-PD target attainment analyses were undertaken using total-drug epithelial lining fluid (ELF) and free-drug plasma exposures to evaluate omadacycline 100 mg intravenously (i.v.) every 12 h or 200 mg i.v. every 24 h (q24h) on day 1, followed by 100 mg i.v. q24h on day 2 and 300 mg orally q24h on days 3 to 5 for patients with CABP.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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