グラム陰性菌血症試験のための迅速な抗生物質感受性検査 (FAST)

介入なし：標準治療

GNBを増殖させた血液培養がランダム化された標準治療群である場合、陽性の血液培養は標準治療の抗菌薬感受性試験（AST）を使用して特徴付けられます。

アクティブコンパレータ：明らかにする

GNB を増殖させている血液培養が Reveal アームにランダム化されると、陽性の血液培養は Reveal、迅速 AST、および標準治療 AST を使用して特徴付けられます。

診断テスト：明らかにする

Reveal は、小分子センサー技術を使用して揮発性代謝産物を測定することで細菌集団の増殖を検出する迅速な AST メソッドで、AST 結果は約 5 時間で得られます。 Reveal™ は欧州連合 (EU) とイスラエルで臨床使用が承認されており、インドでも承認手続き中です。また、微生物の約 90% を占める 28 種類の抗生物質と 9 グラム陰性種の最小発育阻止濃度 (MIC) を提供します。グラム陰性血流感染症（BSI）を引き起こします。

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

入院期間

30日時点で生存している被験者の場合、グラム染色結果後最大30日間の入院期間の長さ。 入院期間は、退院日からグラム染色結果の日付を引いたものとして計算されます。

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.