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A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

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NCT06462235 · readout in 249 d

Sponsored by Pfizer (industry) · PFE — their whole pipeline →. With AbbVie.

Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Basic science
Enrollment
48estimated
Sites
26
Countries
Argentina, India, Israel +2

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-09-25actualWhen the study began enrolling
Primary completion2027-04-25estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-04-25estimatedThe whole study's end, after follow-up
First posted2024-06-17actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-11actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Gram-negative Bacterial Infection

Interventions

  • Drug: Part A: ATM-AVI Single Dose, Cohorts 1-4
  • Drug: Part B: Multiple-dose ATM-AVI, Cohorts 1-4

Primary outcomes

what the primary-completion date above is the date OF
Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI
measured Up to Day 15
Area under the Concentration-Time Curve (AUC) of ATM-AVI
measured Up to Day 15
Plasma Elimination Half-Life (t1/2)
measured Up to Day 15
Apparent Clearance (CL)
measured Up to Day 15
Plasma concentrations of ATM and AVI by nominal sampling time
measured Up to Day 15
Proportion of Participants reporting Adverse Events (AE)
measured Baseline up to Day 50
Proportion of Participants reporting Serious Adverse Events (SAE)
measured Baseline up to Day 50
Proportion of Participants reporting AEs leading to discontinuation of study drug
measured Baseline up to Day 50
Proportion of Participants reporting AEs resulting in death
measured Baseline up to Day 50
Proportion of Participants reporting liver injury and acute kidney injury
measured Baseline up to Day 50

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