A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM-NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) – PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

Pfizer Inc.,0 个研究点目标入组 0 人开始时间: 2018年8月2日最近更新: 2023年9月4日

研究概览

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•1.Subject must be ≥18 years of age.
•2. Evidence of a personally signed and dated informed consent document
•3. Subjects must have a confirmed diagnosis of HAP/VAP, or presumed diagnosis of cIAI requiring administration of IV antibacterial treatmen
•4. Female subject of childbearing potential must have a negative serum or urine pregnancy test, with sensitivity of at least 25 mIU/mL
•5. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Please see the protocol to see the information detailed.

•1.Subject has an APACHE II score >30
•2.At Screening the subject is found to have/or strongly suspected to have an infection caused by a Gram-negative species not expected to respond to either ATM-AVI and/or MER (eg, Acinetobacter baumannii), or an infection caused by only Gram-positive species.
•3.Subject has received more than one day (>24 hours) of any systemic antibiotic within the 48 hours prior to randomization.
•4.Subject has a history of serious allergy such as anaphylaxis, angioedema and bronchospasm, hypersensitivity or any serious reactions to any systemic antibacterial which is allowed per protocol
•5.Subject is unlikely to respond to up to 14 days of study treatment.
•Please see the protocol to see the information detailed.

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