| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06462235 | A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH) | PHASE2 | RECRUITING | 48 | — | — | Sep 25, 2024 | Apr 25, 2027 | Jun 5, 2026 | 27 | United States, Argentina +3 |
Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts.
AUC is a measure of the plasma concentration of ATM and AVI overtime as popPK analysis predicts.
Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts.
ATM and AVI clearance is a quantitative measure of the rate at which ATM and AVI are removed from the blood (rate at which ATM and AVI are metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later) will be summarized by the nominal sampling time using descriptive statistics (eg number, mean, standard deviation).
Proportion of participant AE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each AE the last assessment made prior to the first dose of study drug will be defined as the baseline.
Proportion of participant SAE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each SAE the last assessment made prior to the first dose of study drug will be defined as the baseline.
Proportion of Participants reporting AEs leading to discontinuation of study drug from baseline. For each discontinuation the last assessment made prior to the first dose of study drug will be defined as the baseline.
Proportion of Participants reporting AE resulting in death from baseline. For each death the last assessment made prior to the first dose of study drug will be defined as the baseline.
Proportion of Participants reporting liver injury and acute kidney injury from baseline. For each report of liver and acute kidney injury the last assessment made prior to the first dose of study drug will be defined as the baseline.
| Arm | Type | Description |
|---|---|---|
| Part A, Cohorts 1-4 | EXPERIMENTAL | Single dose pharmacokinetics. |
| Part B, Cohorts 1-4 | EXPERIMENTAL | Multi-dose pharmacokinetics and treatment |
| Name | Type | Description |
|---|---|---|
| Part A: ATM-AVI Single Dose, Cohorts 1-4 | DRUG | Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration. |
| Part B: Multiple-dose ATM-AVI, Cohorts 1-4 | DRUG | Multiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy. |
Inclusion Criteria Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1. Hospitalized with age from birth \<9 months, including preterm birth 2. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, incl...