Pharmacokinetics of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE) in a Phase 1, Open-Label Study of Healthy Adults

Author:

Lodise Thomas P.1ORCID,O’Donnell J. Nicholas1ORCID,Balevic Stephen2,Liu Xing2,Gu Kenan3,George Jomy3,Raja Shruti4ORCID,Guptill Jeffrey T.4,Zaharoff Smitha2,Schwager Nyssa2,Fowler Vance G.2ORCID,Wall Alison5ORCID,Wiegand Katherine5,Chambers Henry F.6ORCID,

Affiliation:

1. Albany College of Pharmacy and Health Sciences, Albany, New York, USA

2. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA

3. Office of Regulatory Affairs (ORA), Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA

4. Duke Early Phase Clinical Research Unit, Duke University School of Medicine, Durham, North Carolina, USA

5. The Emmes Company, Rockville, Maryland, USA

6. University of California, San Francisco, and San Francisco General Hospital, San Francisco, California, USA

Abstract

Scant pharmacokinetic (PK) data are available on ceftazidime-avibactam (CZA) and aztreonam (ATM) in combination, and it is unknown if CZA-ATM exacerbates alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations relative to ATM alone. This phase 1 study sought to describe the PK of CZA-ATM and assess the associations between ATM exposures and ALT/AST elevations.

Funder

HHS | NIH | National Institute of Allergy and Infectious Diseases

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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