Safety of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE) in a Phase I, Open-Label Study in Healthy Adult Volunteers-Reference-Cited by-同舟云学术

Safety of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE) in a Phase I, Open-Label Study in Healthy Adult Volunteers

Published:2022-12-20 Issue:12 Volume:66 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Lodise Thomas P.¹^ORCID,O’Donnell J. Nicholas¹^ORCID,Raja Shruti²^ORCID,Guptill Jeffrey T.²,Zaharoff Smitha³,Schwager Nyssa³,Fowler Vance G.³^ORCID,Beresnev Tatiana⁴^ORCID,Wall Alison⁵^ORCID,Wiegand Katherine⁵,Serti Chrisos Elisavet⁵^ORCID,Balevic Stephen³,Chambers Henry F.⁶^ORCID,

Affiliation:

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

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

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

4. Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA

5. The Emmes Company, Rockville, Maryland, USA

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

Abstract

This phase I study evaluated the safety of the optimal ceftazidime-avibactam (CZA) with aztreonam (ATM) regimens identified in hollow fiber infection models of MBL-producing Enterobacterales. Eligible healthy subjects aged 18 to 45 years were assigned to one of six cohorts: 2.5 g CZA over 2 h every 8 h (approved dose), CZA continuous infusion (CI) (7.5 g daily), 2 g ATM over 2 h every 6 h, ATM CI (8 g daily), CZA (approved dose) with 1.5 g ATM over 2 h every 6 h, and CZA (approved dose) with 2 g ATM over 2 h every 6 h.

Funder

HHS | NIH | National Institute of Allergy and Infectious Diseases

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/aac.00935-22

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