革兰氏阴性菌血症试验的快速抗生素敏感性测试 (FAST)

无干预：护理标准

当血培养生长的 GNB 被随机化为护理标准组时，阳性血培养物将使用护理标准抗菌药物敏感性测试 (AST) 进行表征

有源比较器：揭示

当血培养生长的 GNB 被随机分配到 Reveal 组时，将使用 Reveal、快速 AST 和标准护理 AST 来表征阳性血培养物。

诊断测试：揭示

Reveal 是一种快速 AST 方法，它使用小分子传感器技术通过测量挥发性代谢物来检测细菌种群的生长，并在约 5 小时内提供 AST 结果。 Reveal™ 已在欧盟 (EU) 和以色列获准用于临床，印度正在审批中，并提供 28 种抗生素和 9 种革兰氏阴性菌的最低抑菌浓度 (MIC)，这些菌种合计占生物体的约 90%引起革兰氏阴性血流感染（BSI）。

Participant Clinical Outcomes, as Measured by Desirability of Outcome Ranking (DOOR)

The composite 3-category DOOR outcome will assess three deleterious events (unsuccessful discharge, lack of clinical response, and undesirable events) in addition to survival up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels. From best to worst, they are:

1. Alive without deleterious events
2. Alive with at least 1 deleterious event
3. Death

住院时间

对于 30 天还活着的受试者，革兰氏染色结果后的指数住院时间最长为 30 天。 住院时间的计算方式为出院日期减去革兰氏染色结果的日期。

Number of Participants With All-Cause Mortality

All-cause in-hospital mortality up to 30 days post Gram stain result

Number of Participants With ICU Admissions

ICU admission up to 30 days post Gram stain result

Number of Participants With New Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. Difficile

New acquisition is defined as detection of MDRO/C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months. MDRO will be identified on routine clinical or surveillance samples using local laboratory diagnostic procedures and include:

Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus species 3rd generation cephalosporin-non-susceptible Enterobacterales Carbapenem-resistant Enterobacterales, as defined by the Center for Disease Control and Prevention: resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate produces a carbapenemase Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter species Candida auris

Number of Participants With New Multidrug-Resistant Organism (MDRO)

MDRO will be identified on routine clinical or surveillance samples using local laboratory diagnostic procedures and include:

Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus species 3rd generation cephalosporin-non-susceptible Enterobacterales Carbapenem-resistant Enterobacterales, as defined by the Center for Disease Control and Prevention: resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate produces a carbapenemase Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter species Candida auris

Number of Participants With C. Difficile

Detection of C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months.

Number of Participants With MRSA

Detection of Methicillin-resistant Staphylococcus aureus (MRSA)

Number of Participants With VRE

Detection of Vancomycin-resistant Enterococcus species (VRE)

Number of Participants With CTX Resistant Enterobacterales

Detection of 3rd generation cephalosporin-non-susceptible Enterobacterales (CTX resistant Enterobacterales)

Number of Participants With CRE

Detection of Carbapenem-resistant Enterobacterales (CRE)

Number of Participants With MDR Pseudomonas

Detection of Pseudomonas aeruginosa resistant to carbapenems/multi-drug resistant (MDR Pseudomonas)

Number of Participants With CRAb

Detection of Carbapenem-resistant Acinetobacter species (CRAb)

Number of Participants With Candida Auris

Detection of Candida auris using local laboratory diagnostic precedures

Time to Effective Antibiotic Therapy

Time to effective antibiotic therapy within 3 days from Gram stain result, defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST.

Receiving Effective Antibiotic Therapy Within 24 Hours

Effective antibiotic therapy was defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST and to which the isolate was not intrinsically resistant.

Receiving Effective Antibiotic Therapy Within 3 Days

Effective antibiotic therapy was defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on standard of care (SOC) AST and to which the isolate was not intrinsically resistant.

Time to Antibiotic Escalation or De-escalation

Time to antibiotic escalation or de-escalation of Gram negative coverage in those who have antibiotic change within 3 days from Gram stain result.

Escalation: Changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral (PO) to intravenous (IV) route.

De-escalation: Changing to a narrower spectrum antibiotic , cessation of one or more antibiotics, or changing from an IV to PO route of appropriate drug (i.e. IV to PO ciprofloxacin or levofloxacin).

Antibiotic Change Within 3 Days

Antibiotic changes for Gram-negative coverage within 3 days from Gram stain result.

Among as-randomized population, the antibiotic utilization can be categorized as follow: (a) first change is escalation, (b) first change is de-escalation, (c) no change, and (d) no Gram-negative antibiotic received within 3 days.