EUCTR2017-002742-68-ES进行中（未招募）1 期
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-B-Lactamase (MBL) – Producing Multidrug Resistant Pathogens, for Which There Are Limited or No Treatment Options
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 428
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must be =18 years of age.
- •2. Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.If a subject is unable to consent for themselves at Screening, the subject’s legally acceptable representative may provide written consent, in accordance with the country-specific regulations. Those subjects who are unconscious or considered by the Investigator clinically unable to consent at Screening and who are entered into the study by the consent of a legally acceptable representative should provide their own written informed consent for continuing to
- •participate in the study as soon as possible on recovery, as applicable in accordance with local regulations.
- •3. Subjects must have a confirmed diagnosis of HAP/VAP, or presumed diagnosis of cIAI requiring administration of IV antibacterial treatment
- •4. Female subjects of nonchildbearing potential must meet at least 1 of the following
- •a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;
- •b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- •c. Have medically confirmed ovarian failure.
- •5. Female subject of childbearing potential must have a negative serum or urine pregnancy test, with sensitivity of at least 25 mIU/mL.
- •6. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 128
排除标准
- •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. The subject is allowed to participate in the study if the Investigator considers that the species is a colonizer which does not warrant specific treatment.
- •3. Subject has received more than one day (>24 hours) of any systemic antibiotic within the 48 hours prior to randomization. This is inclusive of all doses of any systemic antibiotic initiated in this time period (but not counting overlapping periods of antibiotics), eg, a subject who receives 4 doses of an 8 hourly regimen with the last dose given just before randomization is calculated as 32 hours of prior antibiotic.
- •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 including ATM, carbapenem, monobactam or other ß-lactam antibiotics, AVI, colistimethate or polymixin B, nitroimidazoles or MTZ, vancomycin, linezolid, daptomycin, aminoglycosides (eg, amikacin, gentamicin, tobramycin), or any of the excipients of the respective (investigational) medicinal products to be administered during the study.
- •5. Subject is unlikely to respond to up to 14 days of study treatment.
研究者
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