Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
← catalyst calendarNCT05639647 · readout in 224 d
Sponsored by Pfizer (industry) · PFE — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
48estimated
Sites
23
Countries
China, Greece, Hungary +5
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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-18 | actual | When the study began enrolling |
| Primary completion | 2027-03-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-12-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Gram-negative Bacterial Infections
Interventions
- Drug: ATM-AVI — also filed as aztreonam plus avibactam
- Drug: BAT — also filed as Best available therapy
Primary outcomes
what the primary-completion date above is the date OFMaximum Predicted Plasma Concentration (Cmax) of ATM and AVI
measured Up to 15 Days
Minimum Predicted Trough Plasma Concentration (Cmin) of ATM and AVI
measured Up to 15 Days
Area under the Concentration-Time Curve (AUC) of ATM-AVI
measured Up to 15 Days
Plasma Decay Half-Life (t1/2)
measured Up to 15 Days
Apparent Clearance (CL)
measured Up to 15 Days
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
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 of ATM-AVI relative to Best Available Therapy (BAT)
measured Baseline up to Day 50
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