Virk Abinash, Strasburg Angel P, Kies Kami D, Donadio Alexander D, Mandrekar Jay, Harmsen William S, Stevens Ryan W, Estes Lynn L, Tande Aaron J, Challener Douglas W, Osmon Douglas R, Fida Madiha, Vergidis Paschalis, Suh Gina A, Wilson John W, Rajapakse Nipunie S, Borah Bijan J, Dholakia Ruchita, Reed Katelyn A, Hines Lisa M, Schuetz Audrey N, Patel Robin
Division of Public Health, Infectious Diseases and Occupational Medicine, Mayo Clinic, Rochester, MN, USA.
Division of Clinical Microbiology, Mayo Clinic, Rochester, MN, USA.
Lancet Microbe. 2024 Dec;5(12):100928. doi: 10.1016/S2666-5247(24)00170-8. Epub 2024 Oct 17.
The clinical utility of rapid multiplex respiratory specimen PCR panels for pneumonia for patients with suspected pneumonia is undefined. We aimed to compare the effect of the BioFire FilmArray pneumonia panel (bioMérieux, Salt Lake City, UT, USA) with standard of care testing on antibiotic use in a real-world hospital setting.
We conducted a single-centre, open-label, pragmatic, randomised controlled trial at the Mayo Clinic, Rochester, MN, USA. Hospitalised patients (aged ≥18 years) with suspected pneumonia, from whom expectorated or induced sputum, tracheal secretions, or bronchoalveolar lavage fluid respiratory culture samples (one per individual) could be collected during index hospitalisation, were eligible for inclusion. Samples from eligible participants were randomly assigned (1:1) with a computerised tool to undergo testing with either the BioFire FilmArray pneumonia panel, conventional culture, and antimicrobial susceptibility testing (intervention group) or conventional culture and antimicrobial susceptibility testing alone (control group). Antimicrobial stewardship review in both groups involved an assessment and recommendations for antibiotic modifications based on clinical data and the results from the BioFire FilmArray pneumonia panel, conventional culture, or both. The primary outcome was median time to first antibiotic modification (ie, escalation or de-escalation of antibiotics against Gram-negative and Gram-positive bacteria) within 96 h of randomisation, assessed with the Wilcoxon rank-sum test and analysed in a modified intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT05937126).
Between Sept 15, 2020, and Sept 19, 2022, 1547 patients were screened for eligibility, of whom 1181 (76·3%) were randomly assigned: 582 (49·3%) to the intervention group and 599 (50·7%) to the control group. In total, 1152 participants were included in the modified intention-to-treat analysis, 589 (51·1%) in the control group and 563 (48·9%) in the intervention group. For the modified intention-to-treat population, median time to any first antibiotic modification was 20·4 h (95% CI 18·0-20·4) in the intervention group and 25·8 h (22·0-28·7) in the control group (p=0·076). Median time to any antibiotic escalation was 13·8 h (9·2-19·0) in the intervention group and 24·1 h (19·5-29·6) in the control group (p=0·0022). Median time to escalation of antibiotics against Gram-positive organisms was 10·3 h (6·2-30·9) in the intervention group and 24·6 h (19·5-37·2) in the control group (p=0·044); median time to escalation of antibiotics against Gram-negative organisms was 17·3 h (10·8-23·3) in the intervention group and 27·2 h (21·3-33·9) in the control group (p=0·010). Median time to any antibiotic de-escalation did not differ between groups (p=0·37). Median time to first de-escalation of antibiotics against Gram-positive organisms was 20·7 h (17·8-24·0) in the intervention group and 27·8 h (22·9-33·0) in the control group (p=0·015); median time to first de-escalation of antibiotics against Gram-negative organisms did not differ between groups (p=0·46).
Clinical use of the BioFire FilmArray pneumonia panel might lead to faster antibiotic escalations, including for Gram-negative or Gram-positive bacteria, and faster antibiotic de-escalations directed at Gram-positive bacteria. Additional research is needed regarding antimicrobial de-escalation, especially when antibiotics with broad Gram-negative spectrum are being used, by use of rapid diagnostics in patients with lower respiratory tract infection.
bioMérieux.
对于疑似肺炎患者，用于肺炎诊断的快速多重呼吸道标本聚合酶链反应（PCR）检测板的临床效用尚不明确。我们旨在比较BioFire FilmArray肺炎检测板（美国犹他州盐湖城bioMérieux公司生产）与标准治疗检测方法在实际医院环境中对患者使用抗生素的影响。
我们在美国明尼苏达州罗切斯特市的梅奥诊所进行了一项单中心、开放标签、实用的随机对照试验。纳入标准为年龄≥18岁、因疑似肺炎住院且在首次住院期间可采集咳出或诱导痰、气管分泌物或支气管肺泡灌洗液体呼吸道培养样本（每人一份）的患者。符合条件的参与者的样本通过计算机工具随机分配（1:1），分别接受BioFire FilmArray肺炎检测板、传统培养和抗菌药物敏感性检测（干预组）或仅接受传统培养和抗菌药物敏感性检测（对照组）。两组的抗菌药物管理审查均包括根据临床数据以及BioFire FilmArray肺炎检测板、传统培养或两者的结果对抗生素调整进行评估并提出建议。主要结局是随机分组后96小时内首次抗生素调整（即针对革兰氏阴性菌和革兰氏阳性菌的抗生素升级或降级）的中位时间，采用Wilcoxon秩和检验进行评估，并在改良意向性分析人群中进行分析。本试验已在ClinicalTrials.gov注册（NCT05937126）。
在2020年9月15日至2022年9月19日期间，1547名患者接受了资格筛查，其中1181名（76.3%）被随机分组：582名（49.3%）分配至干预组，599名（50.7%）分配至对照组。共有1152名参与者纳入改良意向性分析，对照组589名（51.1%），干预组563名（48.9%）。对于改良意向性分析人群，干预组首次进行任何抗生素调整的中位时间为20.4小时（95%CI 18.0 - 20.4），对照组为25.8小时（22.0 - 28.7）（p = 0.076）。干预组任何抗生素升级的中位时间为13.8小时（9.2 - 19.0），对照组为24.1小时（19.5 - 29.6）（p = 0.0022）。干预组针对革兰氏阳性菌的抗生素升级中位时间为10.3小时（6.2 - 30.9），对照组为24.6小时（19.5 - 37.2）（p = 0.044）；干预组针对革兰氏阴性菌的抗生素升级中位时间为17.3小时（10.8 - 23.3），对照组为27.2小时（21.3 - 33.9）（p = 0.010）。两组间任何抗生素降级的中位时间无差异（p = 0.37）。干预组针对革兰氏阳性菌的抗生素首次降级中位时间为20.7小时（17.8 - 24.0），对照组为27.8小时（22.9 - 33.0）（p = 0.015）；干预组和对照组针对革兰氏阴性菌的抗生素首次降级中位时间无差异（p = 0.46）。
BioFire FilmArray肺炎检测板的临床应用可能会使抗生素升级更快，包括针对革兰氏阴性菌或革兰氏阳性菌的升级，以及针对革兰氏阳性菌的抗生素降级更快。对于下呼吸道感染患者，在使用快速诊断方法进行抗菌药物降级方面，尤其是在使用具有广谱革兰氏阴性菌活性的抗生素时，还需要进一步研究。
bioMérieux公司。
