Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
Terminated
Eastern Virginia Medical School
Phase 2
2017-01-01
This study is designed as a masked, two center, randomized, placebo-controlled pilot study to
evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects
with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth
University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential
subjects will be identified in each site's CF clinic.
Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
Terminated
Virginia Commonwealth University
Phase 2
2017-01-01
This study is designed as a masked, two center, randomized, placebo-controlled pilot study to
evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects
with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth
University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential
subjects will be identified in each site's CF clinic.
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.
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