CLINICAL TRIALS PROFILE FOR AVYCAZ
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All Clinical Trials for AVYCAZ
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02504827 ↗ | Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis | Completed | University of Southern California | Phase 4 | 2015-09-01 | The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis. |
| NCT02822950 ↗ | A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients | Completed | Michigan State University | Phase 1 | 2017-01-01 | The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters. |
| NCT03978091 ↗ | A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2019-07-09 | This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion (CI), ATM per label dosing, and ATM as a CI. Arms 5 and 6 are the two AVYCAZ and ATM combination drug administration treatment groups. The duration of subject participation will be up to 44 days, and the total length of the study will be 15 months. The primary objective of this study is to describe the safety of two dosing regimens of AVYCAZ combined with ATM relative to AVYCAZ alone, and ATM alone in healthy adult subjects. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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