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Meta-Analysis
. 2021 May 4;5(5):CD013235.
doi: 10.1002/14651858.CD013235.pub2.

Rapid versus standard antimicrobial susceptibility testing to guide treatment of bloodstream infection

Vanesa Anton-Vazquez  1 , Paul Hine  2 , Sanjeev Krishna  1 , Marty Chaplin  2 , Timothy Planche  3
Affiliations
Meta-Analysis

Rapid versus standard antimicrobial susceptibility testing to guide treatment of bloodstream infection

Vanesa Anton-Vazquez et al. Cochrane Database Syst Rev. .

Abstract
in English, Thai, Spanish

Background: Rapid antimicrobial susceptibility tests are expected to reduce the time to clinically important results of a blood culture. This might enable clinicians to better target therapy to a person's needs, and thereby, improve health outcomes (mortality, length of hospital stay), and reduce unnecessary prescribing of broad-spectrum antibiotics; thereby reducing antimicrobial resistance rates.

Objectives: To assess the effects of rapid susceptibility testing versus standard susceptibility testing for bloodstream infections (BSIs).

Search methods: To identify studies with selected outcomes, we searched the Cochrane Infectious Diseases Group Specialised Register, CENTRAL, MEDLINE, LILACS, and two trials registries, between 1987 and October 2020. We used 'bloodstream infection' and 'antimicrobial susceptibility tests' as search terms. We had no language or publication status limitations.

Selection criteria: Randomized controlled trials (RCTs) comparing rapid antimicrobial susceptibility testing (with a time-to-result of ≤ 8 hours) versus conventional antimicrobial susceptibility testing in people with a BSI caused by any bacteria, as identified by a positive blood culture.

Data collection and analysis: Two review authors independently screened references, full-text reports of potentially relevant studies, extracted data from the studies, and assessed risk of bias. Any disagreement was discussed and resolved with a third review author. For mortality, a dichotomous outcome, we extracted the number of events in each arm, and presented a risk ratio (RR) with 95% confidence interval (CI) to compare rapid susceptibility testing to conventional methods. We used Review Manager 5.4 to meta-analyse the data. For other outcomes, which are time-to-event outcomes (time-to-discharge from hospital, time-to-first appropriate antibiotic change), we conducted qualitative narrative synthesis, due to heterogeneity of outcome measures. MAIN RESULTS: We included six trials, with 1638 participants. For rapid antimicrobial susceptibility testing compared to conventional methods, there was little or no difference in mortality between groups (RR 1.10, 95% CI 0.82 to 1.46; 6 RCTs, 1638 participants; low-certainty evidence). In subgroup analysis, for rapid genotypic or molecular antimicrobial susceptibility testing compared to conventional methods, there was little or no difference in mortality between groups (RR 1.02, 95% CI 0.69 to 1.49; 4 RCTs, 1074 participants; low-certainty evidence). For phenotypic rapid susceptibility testing compared to conventional methods, there was little or no difference in mortality between groups (RR 1.37, 95% CI 0.80 to 2.35; 2 RCTs, 564 participants; low-certainty evidence). In qualitative analysis, rapid susceptibility testing may make little or no difference in time-to-discharge (4 RCTs, 1165 participants; low-certainty evidence). In qualitative analysis, rapid genotypic susceptibility testing compared to conventional testing may make little or no difference in time-to-appropriate antibiotic (3 RCTs, 929 participants; low-certainty evidence). In subgroup analysis, rapid phenotypic susceptibility testing compared to conventional testing may improve time-to-appropriate antibiotic (RR -17.29, CI -45.05 to 10.47; 2 RCTs, 564 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: The theoretical benefits of rapid susceptibility testing have not been demonstrated to directly improve mortality, time-to-discharge, or time-to-appropriate antibiotic in these randomized studies. Future large prospective studies should be designed to focus on the most clinically meaningful outcomes, and aim to optimize blood culture pathways.

บทนำ: การทดสอบความไวต่อยาต้านจุลชีพอย่างรวดเร็วคาดว่าจะช่วยลดเวลาในการให้ผลลัพธ์ที่สำคัญทางคลินิกของการเพาะเชื้อจากเลือด สิ่งนี้อาจช่วยให้แพทย์สามารถกำหนดเป้าหมายการรักษาตามความต้องการของบุคคลได้ดีขึ้น และด้วยเหตุนี้จึงปรับปรุงผลด้านสุขภาพ (อัตราการเสียชีวิต ระยะเวลาการพักรักษาตัวในโรงพยาบาล) และลดการสั่งจ่ายยาปฏิชีวนะครอบคลุมกว้างโดยไม่จำเป็น จึงช่วยลดอัตราการดื้อยาต้านจุลชีพ วัตถุประสงค์: เพื่อประเมินผลของการทดสอบความไวอย่างรวดเร็วเทียบกับการทดสอบความไวแบบมาตรฐานสำหรับการติดเชื้อในกระแสเลือด (BSIs) วิธีการสืบค้น: เพื่อค้นหาการศึกษาสำหรับผลลัพธ์ที่เลือกเราได้สืบค้น Cochrane Infectious Diseases Group Specialised Register, CENTRAL, MEDLINE, LILACS และ trial registries 2 แหล่ง ระหว่างปี 1987 ถึงตุลาคม 2020 เราใช้ 'bloodstream infection' และ 'antimicrobial susceptibility tests' เป็นคำค้นหา เราไม่ใช้ข้อจำกัดด้านภาษาหรือสถานะการตีพิมพ์ เกณฑ์การคัดเลือก: การทดลองแบบสุ่มที่มีกลุ่มควบคุม (RCTs) เปรียบเทียบการทดสอบความไวต่อยาต้านจุลชีพอย่างรวดเร็ว (โดยใช้เวลาถึงผลลัพธ์ ≤ 8 ชั่วโมง) เทียบกับการทดสอบความไวต่อยาต้านจุลชีพแบบเดิมในผู้ที่มี BSI ที่เกิดจากแบคทีเรียใด ๆ ตามที่พบโดยการเพาะเชื้อในเลือดที่เป็นบวก การรวบรวมและวิเคราะห์ข้อมูล: ผู้ประพันธ์การทบทวนวรรณกรรม 2 คนคัดกรองเอกสารอ้างอิง รายงานฉบับเต็มของการศึกษาที่อาจเกี่ยวข้อง คัดลอกข้อมูลจากการศึกษาและประเมินความเสี่ยงของอคติอย่างอิสระต่อกัน กรณีมีความเห็นไม่ตรงกันได้มีการการสนทนากับผู้ประพันธ์การทบทวนวรรณกรรมคนที่ 3 สำหรับการเสียชีวิต dichotomous outcome เราได้คัดลอกจำนวนเหตุการณ์ในแต่ละกลุ่ม และนำเสนอ risk ratio (RR) และช่วงความเชื่อมั่น 95% (CI) เพื่อเปรียบเทียบการทดสอบความไวอย่างรวดเร็วกับวิธีการทั่วไป เราใช้ Review Manager 5.4 ในการวิเคราะห์ข้อมูล สำหรับผลลัพธ์อื่นๆ ซึ่งเป็นผลลัพธ์แบบ time‐to‐event (ระยะเวลาในการจำหน่ายจากโรงพยาบาล การเปลี่ยนยาปฏิชีวนะที่เหมาะสมครั้งแรก) เราได้ทำการสังเคราะห์เชิงคุณภาพแบบบรรยายเนื่องจากผลลัพธ์ที่แตกต่างกัน ผลการวิจัย: เรารวมการทดลอง 6 รายการ โดยมีผู้เข้าร่วม 1638 คน สำหรับการทดสอบความไวต่อยาต้านจุลชีพอย่างรวดเร็วเมื่อเทียบกับวิธีการทั่วไป พบว่าการตายระหว่างกลุ่มมีความแตกต่างกันเล็กน้อยหรือไม่มี (RR 1.10, 95% CI 0.82 ถึง 1.46; 6 RCTs, ผู้เข้าร่วม 1638 คน; หลักฐานมีความเชื่อมั่นในระดับต่ำ) ในการวิเคราะห์กลุ่มย่อยสำหรับการทดสอบความไวต่อยาต้านจุลชีพแบบ genotypic หรือ molecular อย่างรวดเร็ว เมื่อเทียบกับวิธีการทั่วไปพบว่า การตายระหว่างกลุ่มมีความแตกต่างกันเพียงเล็กน้อยหรือไม่มี (RR 1.02, 95% CI 0.69 ถึง 1.49; 4 RCTs, ผู้เข้าร่วม 1074 คน; หลักฐานมีความเชื่อมั่นในระดับต่ำ) สำหรับการทดสอบความไวอย่างรวดเร็วแบบ Phenotypic เมื่อเทียบกับวิธีการทั่วไปพบว่า การตายระหว่างกลุ่มมีความแตกต่างกันเล็กน้อยหรือไม่มี (RR 1.37, 95% CI 0.80 ถึง 2.35; 2 RCTs, ผู้เข้าร่วม 564 คน; หลักฐานมีความเชื่อมั่นในระดับต่ำ) ในการวิเคราะห์เชิงคุณภาพ การทดสอบความไวอย่างรวดเร็วอาจสร้างความแตกต่างเพียงเล็กน้อยหรือไม่มีความแตกต่าง ในเวลาถึงการออกจากโรงพยาบาล (4 RCTs, ผู้เข้าร่วม 1165 คน; หลักฐานมีความเชื่อมั่นในระดับต่ำ) ในการวิเคราะห์เชิงคุณภาพ การทดสอบความไวอย่างรวดเร็วแบบ Genotypic เมื่อเทียบกับการทดสอบแบบเดิมอาจสร้างความแตกต่างเพียงเล็กน้อยหรือไม่มี ในเวลาถึงการให้ยาปฏิชีวนะที่เหมาะสม (3 RCTs, ผู้เข้าร่วม 929 คน; หลักฐานมีความเชื่อมั่นในระดับต่ำ) ในการวิเคราะห์กลุ่มย่อย การทดสอบความไวอย่างรวดเร็วแบบ Phenotypic เมื่อเทียบกับการทดสอบแบบเดิมอาจช่วยปรับปรุงเวลาถึงการให้ยาปฏิชีวนะที่เหมาะสม (RR ‐17.29, CI ‐45.05 ถึง 10.47; 2 RCTs, ผู้เข้าร่วม 564 คน; หลักฐานมีความเชื่อมั่นในระดับต่ำ) ข้อสรุปของผู้วิจัย: ผลประโยชน์ทางทฤษฎีของการทดสอบความไวอย่างรวดเร็วไม่ได้แสดงให้เห็นโดยตรงในการปรับปรุงอัตราการตาย เวลาถึงการออกจากโรงพยาบาล หรือเวลาถึงการให้ยาปฏิชีวนะที่เหมาะสมในการศึกษาแบบสุ่มเหล่านี้ การศึกษาแบบไปข้างหน้าในอนาคตที่มีขนาดใหญ่ควรได้รับการออกแบบมาเพื่อมุ่งเน้นไปที่ผลลัพธ์ที่มีความหมายทางคลินิกมากที่สุด และมีจุดมุ่งหมายเพื่อเพิ่มประสิทธิภาพเส้นทางการเพาะเลี้ยงเชื้อในเลือด.

Antecedentes: Se espera que las pruebas rápidas de susceptibilidad antimicrobiana reduzcan el tiempo de obtención de resultados clínicamente importantes de un hemocultivo. Esto podría permitir a los médicos orientar mejor el tratamiento a las necesidades de la persona y, por tanto, mejorar los desenlaces de salud (mortalidad, duración de la estancia hospitalaria) y reducir la prescripción innecesaria de antibióticos de amplio espectro, con lo que se reducirían las tasas de farmacorresistencia.

Objetivos: Evaluar los efectos de las pruebas rápidas de susceptibilidad versus las pruebas estándares de susceptibilidad para la septicemia. MÉTODOS DE BÚSQUEDA: Para identificar estudios con los desenlaces seleccionados se realizaron búsquedas en el Registro especializado del Grupo Cochrane de Enfermedades infecciosas (Cochrane Infectious Diseases Group), CENTRAL, MEDLINE, LILACS y en dos registros de ensayos, entre 1987 y octubre de 2020. Se utilizaron como términos de búsqueda "bloodstream infection" y "antimicrobial susceptibility tests". No se aplicaron límites de idioma ni de estado de publicación. CRITERIOS DE SELECCIÓN: Ensayos controlados aleatorizados (ECA) que comparan las pruebas rápidas de susceptibilidad antimicrobiana (con un tiempo de obtención de los resultados de ≤ 8 horas) versus las pruebas convencionales de susceptibilidad antimicrobiana en personas con una septicemia causada por cualquier bacteria, identificada por un hemocultivo positivo. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión examinaron de forma independiente las referencias, los informes de texto completo de los estudios potencialmente relevantes, extrajeron los datos de los estudios y evaluaron el riesgo de sesgo. Cualquier desacuerdo se debatió y se resolvió con un tercer autor de la revisión. Para la mortalidad, un desenlace dicotómico, se extrajo el número de eventos en cada grupo, y se presentó una razón de riesgos (RR) con un intervalo de confianza (IC) del 95% para comparar las pruebas rápidas de susceptibilidad con los métodos convencionales. Para realizar los metanálisis de los datos se utilizó Review Manager 5.4. Para otros desenlaces, que son desenlaces de tiempo hasta el evento (tiempo transcurrido hasta el alta hospitalaria, tiempo transcurrido hasta el primer cambio apropiado de antibiótico), se realizó una síntesis narrativa cualitativa debido a la heterogeneidad de las medidas de desenlace.

Resultados principales: Se incluyeron seis ensayos con 1638 participantes. En el caso de las pruebas rápidas de susceptibilidad antimicrobiana comparadas con los métodos convencionales, hubo poca o ninguna diferencia en la mortalidad entre los grupos (RR 1,10; IC del 95%: 0,82 a 1,46; seis ECA, 1638 participantes; evidencia de certeza baja). En el análisis de subgrupos, para las pruebas rápidas de susceptibilidad antimicrobiana genotípicas o moleculares en comparación con los métodos convencionales, hubo poca o ninguna diferencia en la mortalidad entre los grupos (RR 1,02; IC del 95%: 0,69 a 1,49; cuatro ECA, 1074 participantes; evidencia de certeza baja). En el caso de las pruebas rápidas de susceptibilidad fenotípicas en comparación con los métodos convencionales hubo poca o ninguna diferencia en la mortalidad entre los grupos (RR 1,37; IC del 95%: 0,80 a 2,35; dos ECA, 564 participantes; evidencia de certeza baja). En el análisis cualitativo, las pruebas rápidas de susceptibilidad podrían suponer una diferencia escasa o nula en el tiempo transcurrido hasta el alta (cuatro ECA, 1165 participantes; evidencia de certeza baja). En el análisis cualitativo, las pruebas rápidas de susceptibilidad genotípicas comparadas con las pruebas convencionales podrían suponer una diferencia escasa o nula en el tiempo transcurrido hasta recibir el antibiótico apropiado (tres ECA, 929 participantes; evidencia de certeza baja). En el análisis de subgrupos, las pruebas rápidas de susceptibilidad fenotípicas comparadas con las pruebas convencionales podrían mejorar el tiempo transcurrido hasta recibir el antibiótico apropiado (RR ‐17,29; IC: ‐45,05 a 10,47; dos ECA, 564 participantes; evidencia de certeza baja).

Conclusiones de los autores: Los beneficios teóricos de las pruebas rápidas de susceptibilidad no han mostrado mejorar directamente la mortalidad, el tiempo transcurrido hasta el alta ni el tiempo transcurrido hasta recibir el antibiótico apropiado en estos estudios aleatorizados. Los estudios prospectivos futuros de gran envergadura se deben diseñar para centrarse en los desenlaces más importantes desde el punto de vista clínico y tener como objetivo optimizar las vías de hemocultivo.

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Conflict of interest statement

VA has no known conflicts of interest.

PH was previously employed full‐time by Cochrane Infectious Diseases Group (CIDG), and currently works full‐time within the UK National Health Service (NHS). He received a Registration Scholarship to attend the 23rd Annual British HIV Association Conference 2017 from ViiV healthcare. ViiV had no involvement in the selection of recipients of the scholarship. In 2018, he attended a CPD‐certified clinical research training programme, organized and funded by Gilead Sciences Europe Ltd. To the best of his knowledge, neither financial or non‐financial conflicts of interests have influenced the current submitted work.

SK is a scientific advisor and shareholder in QuantuMDx, a company that is developing rapid diagnostic tests for several infections, and is a scientific advisor to Foundation for Innovative New Diagnostics (FIND). The opinions in this review are personal opinions, and do not represent views of either organization.

MC has no known conflicts of interest.

TP is the clinical lead of a NHS diagnostic microbiology laboratory at South West London Pathology. He is on advisory boards for Roche, Pfizer, and Singulex for diagnostics.

Figures

1
1
Time to appropriate antibiotics: time to first appropriate antibiotic (from collection time of positive blood culture to start of an antibiotic which has in vitro activity versus the identified organism)
2
2
Flowchart of study selection
3
3
Risk of bias summary: a summary table of review authors' judgements for each risk of bias item for each study.
4
4
Risk of bias graph: a plot of the distribution of review authors' judgements across studies for each risk of bias item.
1.1
1.1. Analysis
Comparison 1: Rapid versus standard antibiotic susceptibility testing, Outcome 1: Mortality (subgroups: genotypic, phenotypic)
1.2
1.2. Analysis
Comparison 1: Rapid versus standard antibiotic susceptibility testing, Outcome 2: Mortality (subgroups: antimicrobial stewardship, without antimicrobial stewardship)
1.3
1.3. Analysis
Comparison 1: Rapid versus standard antibiotic susceptibility testing, Outcome 3: Mortality (subgroups: rapid ID and AST, AST alone
1.4
1.4. Analysis
Comparison 1: Rapid versus standard antibiotic susceptibility testing, Outcome 4: Time‐to‐appropriate antibiotic (phenotypic testing)
See this image and copyright information in PMC

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References

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Allaouchiche 1999 {published data only}
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References to ongoing studies

ChiCTR2000034973 {published data only}
    1. ChiCTR2000034973. Clinical research of early rapid pathogen identification strategy for sepsis. chictr.org.cn/hvshowproject.aspx?id=44958 (last refreshed 26 July 2020).
NCT03744728 {published data only}
    1. NCT03744728. Randomized trial of fast bacterial identification and phenotypic antimicrobial susceptibility testing in patients with positive blood cultures using the Accelerate PhenoTest™ BC kit, performed on the Accelerate Pheno™ System as compared with the Verigene® BC-GP/GN. clinicaltrials.gov/ct2/show/NCT03744728 (first posted 16 November 2018).
NCT03745014 {published data only}
    1. NCT03745014. Clinical impact of fast phenotypic antimicrobial susceptibility testing on patients with Gram-negative rod bacteremia. clinicaltrials.gov/ct2/show/NCT03745014 (first posted 19 November 2018).
NCT03876990 {published data only}
    1. NCT03876990. Clinical and medico-economic evaluation of a rapid test (ePlex-BCID®, GenMark) for the diagnosis of bacteremia and fungemia (HEMOFAST). clinicaltrials.gov/ct2/show/NCT03876990?cond=NCT03876990 (first posted 15 March 2019).
NCT04153682 {published data only}
    1. NCT04153682. Trial on a strategy combining rapid diagnostic testing and antimicrobial stewardship to improve antibiotic use in patients with hospital-acquired pneumonia (SHARP). clinicaltrials.gov/ct2/show/NCT04153682 (first posted 6 November 2019).

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References to other published versions of this review

Anton‐Vazquez  2018
    1. Anton‐Vazquez V, Hine P, Krishna S, Richardson M, Planche T. Rapid versus standard antibiotic susceptibility testing for treating bloodstream infections. Cochrane Database of Systematic Reviews 2018, Issue 12. Art. No: CD013235. [DOI: 10.1002/14651858.CD013235] - DOI - PMC - PubMed

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