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Part A: ATM-AVI Single Dose, Cohorts 1-4

Phase 2

Gram-negative Bacterial Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06462235A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)PHASE2 RECRUITING 48Sep 25, 2024Apr 25, 2027Jun 5, 202627 United States, Argentina +3
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Study Endpoints
Primary Endpoints
Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI
Up to Day 15

Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts.

Area under the Concentration-Time Curve (AUC) of ATM-AVI
Up to Day 15

AUC is a measure of the plasma concentration of ATM and AVI overtime as popPK analysis predicts.

Plasma Elimination Half-Life (t1/2)
Up to Day 15

Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts.

Apparent Clearance (CL)
Up to Day 15

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 by nominal sampling time
Up to Day 15

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 Participants reporting Adverse Events (AE)
Baseline up to Day 50

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 Participants reporting Serious Adverse Events (SAE)
Baseline up to Day 50

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
Baseline up to Day 50

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 AEs resulting in death
Baseline up to Day 50

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
Baseline up to Day 50

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.

Secondary Endpoints
Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of IV study treatment (EOIV)
Up to 15 days after start of IV study treatment
Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of treatment (EOT)
Within 48 hours after last dose of oral switch treatment
Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at test of cure (TOC)
7-14 days after the last study treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A, Cohorts 1-4EXPERIMENTALSingle dose pharmacokinetics.
Part B, Cohorts 1-4EXPERIMENTALMulti-dose pharmacokinetics and treatment
Interventions
NameTypeDescription
Part A: ATM-AVI Single Dose, Cohorts 1-4DRUGSingle intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration.
Part B: Multiple-dose ATM-AVI, Cohorts 1-4DRUGMultiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy.
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Eligibility Criteria
Age RangeN/A — 39 Weeks
SexALL
Healthy VolunteersNo
Study Sites27

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...

Countries:United StatesArgentinaIndiaIsraelTaiwan
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT06462235lastUpdatePostDate: changed
LOWJun 5, 2026NCT06462235lastUpdatePostDate: changed
LOWJun 5, 2026NCT06462235lastUpdatePostDate: changed
LOWJun 5, 2026NCT06462235lastUpdatePostDate: changed
LOWMay 26, 2026NCT06462235primaryCompletionDate: changed
LOWMay 24, 2026NCT06462235studyFirstPostDate: changed