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Comparison between meropenem and ceftolozane/tazobactam: possible influence of CRRT
Critical Care ( IF 8.8 ) Pub Date : 2022-01-07 , DOI: 10.1186/s13054-021-03837-6
Patrick M Honore 1 , Sebastien Redant 1 , Thierry Preseau 2 , Sofie Moorthamers 2 , Keitiane Kaefer 1 , Leonel Barreto Gutierrez 3 , Rachid Attou 1 , Andrea Gallerani 1 , Willem Boer 4 , David De Bels 1
Affiliation  

In their recent study [1], Timsit et al. conclude that mortality risk with ventilator hospital-acquired bacterial pneumonia (vHABP) was over twice as high when treated with meropenem compared to ceftolozane/tazobactam (C/T). However, the percentage of patients in the database with vHABP who had a creatinine clearance (CrCl) between 15 and 30 ml/min was 12% in both groups [1]. Of these, around 40% had a sequential organ failure assessment (SOFA) score > 7 with vasopressor use in more than 50% in both groups. Consequently, it is reasonable to assume that most of these patients were undergoing renal replacement therapy (RRT), most likely continuous RRT (CRRT) though this was not reported [1]. While a dose of C/T of 3 gr (2 g ceftolozane and 1 g tazobactam) three times a day will surely be above the minimal inhibitory concentration (MIC) most of the time even on CRRT [2], this is not the case for meropenem 1 gr three times a day, as in a number of cases this dose will fall below the MIC when undergoing CRRT [1]. Kothekar et al. concluded that in septic shock patients, extended infusions (EI) of 1000 mg of meropenem over 3 h, administered every 8 h, provided adequate coverage against sensitive strains of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter baumannii [3]. However, this dosing regimen failed to achieve a fraction of time (fT) > 4 μg/mL > 40 for activity against more resistant strains of these organisms in more than one-third of patients [3]. A bolus of 500 mg followed by EI of 1500 mg every 8 h was predicted to achieve this target in all patients [3]. If drug dose adaptation was not adhered to in CRRT patients and continuous infusion (CI) not used in cases of pathogens with a MIC ≥ 4, as recommended [4] some patients may have been underdosed, even with 1 g every 8 h [3, 4], as meropenem is significantly eliminated by CRRT [4]. In addition, in the same study adjunctive therapy with amikacin 15 mg/kg was permitted for the first 72 h of study treatment where ≥ 15% of Pseudomonas aeruginosa were known to be meropenem resistant [1]. Under CRRT, the recommended dose of amikacin to avoid failure is 25 mg/kg [5]. In conclusion, underdosing of antibiotics in patients undergoing CRRT may go some way to explaining the findings reported by Timsit et al.

  • Jean‑François Timsit,
  • Jennifer A. Huntington,
  • Richard G. Wunderink,
  • Marin H. Kollef,
  • Ignacio Martin‑Loeches,
  • Brian Yu,
  • Erin H. Jensen,
  • Dominik J. Wolf &
  • Christopher J. Bruno 

  1. Intensive Care Medicine Department, Université Paris Diderot, Paris, France

    Jean‑François Timsit

  2. MRL, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA

    Jennifer A. Huntington, Brian Yu, Erin H. Jensen, Dominik J. Wolf & Christopher J. Bruno

  3. Pulmonary and Critical Care Division, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Richard G. Wunderink

  4. Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO, USA

    Marin H. Kollef

  5. Department of Intensive Care Medicine, Multidisciplinary Intensive Care Research Organization (MICRO), St James’ Hospital, Dublin, Ireland

    Ignacio Martin‑Loeches

  6. Hospital Clinic, Universitat de Barcelona, IDIBAPS, CIBERES, Barcelona, Spain

    Ignacio Martin‑Loeches

Dear Editor,

We appreciate the letter from Honore et al. expressing concern about the potential for underdosing meropenem in participants who may have received renal replacement therapy (RRT) in our study [1]. Honore et al. assumed that because 40% of participants in our subgroup analysis had sequential organ failure assessment scores > 7 and ≈50% received concomitant vasopressors, most would have undergone continuous RRT (CRRT). However, this was not the case.

Per the study protocol, any requirement for peritoneal dialysis or hemodialysis or hemofiltration were exclusion criteria and RRT was not permitted during study treatment. Any participant who developed creatinine clearance (CrCl) < 15 mL/min or was placed on RRT was required to be withdrawn from randomized study treatment and switched to standard-of-care antibacterial therapy, because optimal dosing recommendations for participants with renal impairment receiving RRT had not been determined for ceftolozane/tazobactam or meropenem at the time the study was conducted. The current meropenem label still lacks dosing recommendations for patients undergoing RRT [6]. We agree with Honore et al. that inclusion of participants receiving RRT in the meropenem arm would have been of concern.

Recently, several studies have been conducted to determine optimal dosing of ceftolozane/tazobactam in adults with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) and renal impairment or augmented renal clearance (ARC). The results suggest that the following ceftolozane/tazobactam doses, administered every 8 h according to renal function, are recommended for adults with HABP/VABP [7,8,9]: CrCl > 50 mL/min (including critically ill patients with ARC): 3 g; CrCl 30 to ≤ 50 mL/min: 1.5 g; CrCl 15 to < 30 mL/min: 750 mg; and end-stage renal disease on hemodialysis: single loading dose of 2.25 g, followed by 450 mg every 8 h.

Importantly, among the ventilated HABP (vHABP) subgroup, only 1 of the 108 participants in the meropenem arm underwent RRT, including CRRT, while on study treatment (i.e., a protocol deviation). Thus, the influence of RRT on the analysis and interpretation of results reported for participants with vHABP treated with meropenem was exceedingly small. None of the 99 participants with vHABP in the ceftolozane/tazobactam treatment arm received RRT while on treatment.

In conclusion, RRT was not permitted during study treatment, and only 1 participant in the vHABP subgroup deviated from the protocol and received CRRT during study treatment. Therefore, underdosing of meropenem in the setting of RRT did not appreciably affect the findings of our recently published analysis of participants with vHABP [1].

Not applicable.

vHABP:

Ventilator hospital-acquired bacterial pneumonia

C/T:

Ceftolozane/tazobactam

ClCr:

Creatinine clearance

SOFA:

Sequential organ failure assessment

RRT:

Renal replacement therapy

Continuous RRT:

Continuous renal replacement therapy

MIC:

Minimal inhibitory concentration

EI:

Extended infusions

fT:

Fraction of time

CI:

Continuous infusion

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    Timsit JF, Huntington JA, Wunderink RG, et al. Ceftolozane/tazobactam versus meropenem in patients with ventilated hospital-acquired bacterial pneumonia: subset analysis of the ASPECT-NP randomized, controlled phase 3 trial. Crit Care. 2021;25(1):290. https://doi.org/10.1186/s13054-021-03694-3 (PMID: 34380538; PMCID: PMC8356211).

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Affiliations

  1. ICU Department, Centre Hospitalier Universitaire Brugmann-Brugmann University Hospital, Place Van Gehuchtenplein, 4, 1020, Brussels, Belgium

    Patrick M. Honore, Sebastien Redant, Keitiane Kaefer, Rachid Attou, Andrea Gallerani & David De Bels

  2. ED Department, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium

    Thierry Preseau & Sofie Moorthamers

  3. ICU Department, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium

    Leonel Barreto Gutierrez

  4. Intensive Care Department, Ziekenhuis Oost Limburgh, Campus St Jan, Genk, Belgium

    Willem Boer

Authors
  1. Patrick M. HonoreView author publications

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  7. Rachid AttouView author publications

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  8. Andrea GalleraniView author publications

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  9. Willem BoerView author publications

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Contributions

PMH, SM, SR, WB, and DDB designed the paper. All authors participated in drafting and reviewing. All authors read and approved the final version of the manuscript.

Corresponding authors

Correspondence to Patrick M. Honore or Christopher J. Bruno.

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Honore, P.M., Redant, S., Preseau, T. et al. Comparison between meropenem and ceftolozane/tazobactam: possible influence of CRRT. Crit Care 26, 15 (2022). https://doi.org/10.1186/s13054-021-03837-6

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Keywords

  • Ventilator hospital-acquired bacterial pneumonia
  • Ceftolozane/tazobactam, meropenem
  • CRRT
  • Confounders

中文翻译：
美罗培南与头孢唑烷/他唑巴坦的比较：CRRT的可能影响

在他们最近的研究 [1] 中，Timsit 等人。得出结论，与头孢唑烷/他唑巴坦 (C/T) 相比，使用美罗培南治疗呼吸机医院获得性细菌性肺炎 (vHABP) 的死亡风险高出两倍以上。然而，数据库中肌酐清除率 (CrCl) 介于 15 和 30 ml/min 之间的 vHABP 患者的百分比在两组中均为 12% [1]。其中，约 40% 的患者序贯器官衰竭评估 (SOFA) 评分 > 7，两组中血管加压药的使用率均超过 50%。因此，可以合理地假设这些患者中的大多数正在接受肾脏替代治疗 (RRT)，最有可能是持续 RRT (CRRT)，尽管这没有被报道 [1]。虽然每天 3 次 3 克（2 克头孢洛扎恩和 1 克他唑巴坦）的 C/T 剂量在大多数情况下肯定会高于最低抑菌浓度 (MIC)，即使在 CRRT [2] 上也是如此，但情况并非如此对于美罗培南 1 克，每天 3 次，因为在许多情况下，在接受 CRRT 时，该剂量将低于 MIC [1]。Kothekar 等人。得出的结论是，在感染性休克患者中，每 8 小时一次，在 3 小时内延长输注 1000 毫克美罗培南 (EI)，可以充分覆盖肠杆菌科的敏感菌株，铜绿假单胞菌和鲍曼不动杆菌[3]。然而，这种给药方案未能在超过三分之一的患者中实现对这些生物体的耐药性更强的菌株的活性时间分数 (fT) > 4 μg/mL > 40 [3]。预计每 8 小时一次 500 mg 的推注，随后 1500 mg 的 EI 可以在所有患者中实现这一目标 [3]。如果在 CRRT 患者中不遵守药物剂量调整，并且在 MIC ≥ 4 的病原体的情况下不使用持续输注 (CI)，则按照建议 [4] 一些患者可能剂量不足，即使每 8 小时 1 g [3 , 4]，因为 CRRT [4] 显着消除了美罗培南。此外，在同一研究中，允许在研究治疗的前 72 小时内使用阿米卡星 15 mg/kg 进行辅助治疗，其中≥ 15%已知铜绿假单胞菌对美罗培南具有耐药性 [1]。在 CRRT 下，避免失败的阿米卡星推荐剂量为 25 mg/kg [5]。总之，在接受 CRRT 的患者中抗生素剂量不足可能在某种程度上解释了 Timsit 等人报告的发现。

  • 让-弗朗索瓦·蒂姆西特，
  • 詹妮弗·A·亨廷顿，
  • 理查德 G. Wunderink，
  • 马林·H·科勒夫，
  • 伊格纳西奥·马丁·洛切斯，
  • 布莱恩·于
  • 艾琳·H·詹森，
  • 多米尼克·J·沃尔夫 &
  • 克里斯托弗·J·布鲁诺 

  1. 法国巴黎狄德罗大学重症监护医学系

    让-弗朗索瓦·蒂姆西特

  2. MRL, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA

    Jennifer A. Huntington、Brian Yu、Erin H. Jensen、Dominik J. Wolf 和 Christopher J. Bruno

  3. 美国伊利诺伊州芝加哥西北大学范伯格医学院肺和重症监护科

    理查德 G. Wunderink

  4. 美国密苏里州圣路易斯华盛顿大学医学院肺和重症监护医学部

    马林·H·科勒夫

  5. 爱尔兰都柏林圣詹姆斯医院多学科重症监护研究组织 (MICRO) 重症监护医学系

    伊格纳西奥·马丁·洛切斯

  6. 医院诊所，巴塞罗那大学，IDIBAPS，CIBERES，巴塞罗那，西班牙

    伊格纳西奥·马丁·洛切斯

亲爱的编辑，

我们感谢 Honore 等人的来信。对在我们的研究中可能接受过肾脏替代治疗 (RRT) 的参与者美罗培南剂量不足的可能性表示担忧 [1]。奥诺雷等人。假设因为在我们的亚组分析中 40% 的参与者的序贯器官衰竭评估分数 > 7 并且 ≈50% 接受了伴随的血管加压药，大多数人会接受连续 RRT (CRRT)。然而，事实并非如此。

根据研究方案，对腹膜透析或血液透析或血液滤过的任何要求都是排除标准，并且在研究治疗期间不允许进行 RRT。任何出现肌酐清除率 (CrCl) < 15 mL/min 或接受 RRT 的参与者都必须退出随机研究治疗并改用标准护理抗菌治疗，因为接受 RRT 的肾功能不全参与者的最佳剂量建议在进行研究时，尚未确定头孢唑烷/他唑巴坦或美罗培南。当前的美罗培南标签仍然缺乏对接受 RRT 的患者的剂量建议 [6]。我们同意 Honore 等人的观点。将接受 RRT 的参与者纳入美罗培南组会引起关注。

最近，已经进行了几项研究，以确定头孢唑烷/他唑巴坦在患有医院获得性细菌性肺炎/呼吸机相关性细菌性肺炎 (HABP/VABP) 和肾功能不全或肾清除率增加 (ARC) 的成人中的最佳剂量。结果表明，对于 HABP/VABP 的成人，建议每 8 小时给药一次的以下头孢唑烷/他唑巴坦剂量 [7,8,9]：CrCl > 50 mL/min（包括患有 ARC 的危重患者） : 3 克; CrCl 30 至 ≤ 50 mL/min：1.5 g；CrCl 15 至 < 30 mL/min：750 mg；和终末期肾病血液透析：单次负荷剂量 2.25 g，随后每 8 小时 450 mg。

重要的是，在通气 HABP (vHABP) 亚组中，美罗培南组的 108 名参与者中只有 1 名在研究治疗期间接受了 RRT，包括 CRRT（即方案偏差）。因此，RRT 对接受美罗培南治疗的 vHABP 参与者报告的结果分析和解释的影响非常小。头孢唑烷/他唑巴坦治疗组中的 99 名 vHABP 参与者在治疗期间均未接受 RRT。

总之，研究治疗期间不允许进行 RRT，并且 vHABP 亚组中只有 1 名参与者偏离了方案并在研究治疗期间接受了 CRRT。因此，在 RRT 中美罗培南剂量不足不会明显影响我们最近发表的对 vHABP 参与者的分析结果 [1]。

不适用。

vHABP：

呼吸机医院获得性细菌性肺炎

货/吨：

头孢唑烷/他唑巴坦

氯化铬：

肌酐清除率

沙发：

序贯器官衰竭评估

RRT：

肾脏替代疗法

连续 RRT：

持续肾脏替代治疗

麦克风：

最低抑菌浓度

EI：

延长输液

英尺：

时间分数

CI：

连续输液

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    Shorr AF、Bruno CJ、Zhang Z、Jensen E、Gao W、Feng HP、Huntington JA、Yu B、Rhee EG、De Anda C 等。随机 3 期 ASPECT-NP 试验中肾清除率增加的参与者的头孢唑烷/他唑巴坦达到目标的概率和结果。暴击护理。2021；25(1):354。

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隶属关系

  1. ICU 部门，Center Hospitalier Universitaire Universitaire Brugmann-Brugmann University Hospital, Place Van Gehuchtenplein, 4, 1020, Brussels, Belgium

    Patrick M. Honore、Sebastien Redant、Keitiane Kaefer、Rachid Attou、Andrea Gallerani 和 David De Bels

  2. 比利时布鲁塞尔布鲁格曼大学中心医院急诊科

    蒂埃里·普雷索和索菲·穆尔萨默斯

  3. 比利时布鲁塞尔布鲁格曼大学中心医院重症监护室

    莱昂内尔·巴雷托·古铁雷斯

  4. 重症监护室，Ziekenhuis Oost Limburgh，Campus St Jan，Genk，比利时

    威廉波尔

作者
  1. Patrick M. Honore查看作者出版物

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  2. Sebastien Redant查看作者的出版物

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  3. Thierry Preseau查看作者的出版物

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  4. Sofie Moorthamers查看作者的出版物

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  5. Keitiane Kaefer查看作者的出版物

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  6. Leonel Barreto Gutierrez查看作者的出版物

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  7. Rachid Attou查看作者的出版物

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  8. Andrea Gallerani查看作者的出版物

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  9. Willem Boer查看作者的出版物

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  10. David De Bels查看作者的出版物

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贡献

PMH、SM、SR、WB 和 DDB 设计了这篇论文。所有作者都参与了起草和审查。所有作者都阅读并批准了手稿的最终版本。

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引用这篇文章

Honore, PM, Redant, S., Preseau, T.等。美罗培南和头孢唑烷/他唑巴坦的比较：CRRT的可能影响。重症监护 26, 15 (2022)。https://doi.org/10.1186/s13054-021-03837-6

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  • DOI ：https ://doi.org/10.1186/s13054-021-03837-6

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关键词

  • 呼吸机医院获得性细菌性肺炎
  • 头孢唑烷/他唑巴坦、美罗培南
  • CRRT
  • 混杂因素
更新日期：2022-01-08
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