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Label indication AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients (at least 31 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole ( 1.1 ) Complicated Urinary Tract Infections… FDA label
Also known as Avibactam (AVI)
Avibactam · 1 trial · 2 indications
from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.
| Arm | Type | Description |
|---|---|---|
| Drug: A | EXPERIMENTAL | Avibactam (AVI) |
| Drug: B | EXPERIMENTAL | Aztreonam (ATM) |
| Drug: C | EXPERIMENTAL | combination of Aztreonam-Avibactam (ATM-AVI) |
| Drug: D | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| Avibactam (AVI) | DRUG | PART A: AVI IV infusion |
| Aztreonam (ATM) | DRUG | PART A: ATM IV infusion |
| combination of Aztreonam - Avibactam (ATM-AVI) | DRUG | PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions. |
| Placebo | DRUG | PART A, PART B, PART C: matching placebo IV infusions |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (Part C) with suitable veins for cannulation or repeated ve...
Avibactam is a small molecule developed by Pfizer, Inc. (ticker PFE) as part of a combination antibacterial therapy for complicated infections, including bacterial infections. It is an investigational agent in clinical development and is being studied in combination with aztreonam under the name aztreonam-avibactam (ATM-AVI).
Avibactam is being developed for complicated infections, including bacterial infections, as a component of combination antibacterial therapy. It is studied together with aztreonam as aztreonam-avibactam (ATM-AVI). It is investigational and has not been established as a marketed treatment for these infections.
Avibactam is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for aztreonam-avibactam (ATM-AVI), the combination in which avibactam is being studied for complicated infections.
Avibactam is in Phase 1 clinical development. The completed Phase 1 trial evaluated the safety and tolerability of aztreonam-avibactam (ATM-AVI). Avibactam is investigational and is not an approved product based on this development stage.
Avibactam has been studied in the Phase 1 trial NCT01689207, titled "To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)." That trial enrolled 222 participants in the United Kingdom, was randomized, double-blind, and placebo-controlled, and has completed. It included healthy volunteers aged 18 years and older.
Yes. Avibactam is also referred to as Avibactam (AVI). Both names refer to the same small molecule being developed by Pfizer, Inc. (ticker PFE) as part of the aztreonam-avibactam (ATM-AVI) combination for complicated infections, including bacterial infections.