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联合使用呼吸道多重聚合酶链反应和降钙素原以减少镰状细胞病成年急性胸综合征患者的抗生素暴露(ANTIBIO-STA研究):一项随机、对照、开放标签试验

Combined use of respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in sickle-cell adult patients with acute chest syndrome (The ANTIBIO-STA study): a randomised, controlled, open-label trial.

作者信息

Sabaté-Elabbadi Alexandre, Mekontso-Dessap Armand, Lionnet François, Santin Aline, Verdet Charlotte, Woerther Paul-Louis, Lopinto Julien, Turpin Matthieu, Rousseau Alexandra, Lacoste-Badie Romane, Razazi Keyvan, Voiriot Guillaume, Fartoukh Muriel

机构信息

Sorbonne Université, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, Paris, France.

Hôpitaux universitaires Henri Mondor, Assistance Publique - Hôpitaux de Paris, DMU Médecine, Service de Médecine Intensive Réanimation, Hôpital Henri Mondor, Créteil, France.

出版信息

Lancet Reg Health Eur. 2025 Feb 7;51:101234. doi: 10.1016/j.lanepe.2025.101234. eCollection 2025 Apr.

DOI:10.1016/j.lanepe.2025.101234
PMID:39995490
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11849121/
Abstract

BACKGROUND

Respiratory infection may account for 30% of acute chest syndrome (ACS) aetiologies. However, antimicrobials are routinely prescribed, and de-escalation and/or discontinuation are challenging. Multiplex Polymerase Chain Reaction (mPCR) with an enlarged respiratory panel might support antimicrobial stewardship, and procalcitonin (PCT) measurements help reduce duration of antibiotic therapy. We hypothesized that a strategy combining the use of mPCR with repeated PCT measurements would reduce antibiotic exposure during ACS.

METHODS

We conducted a randomised, controlled, parallel group, open-label study in two French hospitals. Consecutive adult patients with ACS were randomly assigned to the conventional or interventional strategy, where antibiotic therapy was targeted on the results of mPCR performed on lower respiratory tract secretions (LRTS) samples, and antibiotic discontinuation based on PCT values and kinetics at Day 1 (D1), D3 and D7. The primary outcome was the number of days of antibiotic exposure at D28 after randomisation. This trial was registered on ClinicalTrial.gov (NCT03919266) and is closed to recruitment.

FINDINGS

From June 2020 to September 2022, 72 patients were assigned to the interventional (n = 37) or conventional strategy (n = 35). Despite a higher rate of microbiological documentation with the intervention (n = 25; 67.6% versus n = 13; 37.1%; difference, 30.4%; 95% CI 6.7%-51.5%), antibiotic exposure at D28 was similar between the two strategies (6 days [4.0-8.0] versus 6 days [5.0-9.0], respectively; difference, 0.0 day; 95% CI, -2.1 to 2.1). The time to clinical stability, and ICU and hospital lengths of stay did not differ.

INTERPRETATION

As compared with conventional tests, an enlarged respiratory panel mPCR combined with a PCT-guided algorithm did not reduce antibiotic exposure at D28 in adults with ACS.

FUNDING

Assistance Publique-Hôpitaux de Paris, AP-HP (CRC180159). A financial support for the multiplex PCR kits used in this study was partially provided by bioMérieux.

摘要

背景

呼吸道感染可能占急性胸部综合征(ACS)病因的30%。然而,抗菌药物通常是常规使用的,降阶梯和/或停药具有挑战性。采用扩大呼吸道检测组的多重聚合酶链反应(mPCR)可能有助于抗菌药物管理,而降钙素原(PCT)检测有助于缩短抗生素治疗疗程。我们假设,将mPCR与重复的PCT检测相结合的策略将减少ACS期间的抗生素暴露。

方法

我们在两家法国医院进行了一项随机、对照、平行组、开放标签研究。连续纳入的成年ACS患者被随机分配至传统策略组或干预策略组,其中抗生素治疗以在下呼吸道分泌物(LRTS)样本上进行的mPCR结果为靶向,并根据第1天(D1)、第3天和第7天的PCT值及动态变化停用抗生素。主要结局是随机分组后第28天的抗生素暴露天数。该试验已在美国国立医学图书馆临床试验注册库(ClinicalTrial.gov)注册(NCT03919266),现已结束招募。

结果

2020年6月至2022年9月,72例患者被分配至干预策略组(n = 37)或传统策略组(n = 35)。尽管干预组的微生物学确诊率更高(n = 25;67.6% 对比 n = 13;37.1%;差异为30.4%;95%CI 6.7%-51.5%),但两组在第28天的抗生素暴露情况相似(分别为6天[4.0 - 8.0]和6天[5.0 - 9.0];差异为0.0天;95%CI,-2.1至2.1)。临床稳定时间、重症监护病房(ICU)住院时间和住院总时长无差异。

解读

与传统检测相比,扩大呼吸道检测组的mPCR联合PCT指导算法并未减少成年ACS患者在第28天的抗生素暴露。

资金来源

巴黎公立医院集团(AP-HP,CRC180159)。本研究中使用的多重PCR试剂盒的资金支持部分由生物梅里埃公司提供。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92c0/11849121/cfae21e5cede/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92c0/11849121/b0016c7098ef/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92c0/11849121/cfae21e5cede/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92c0/11849121/b0016c7098ef/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92c0/11849121/cfae21e5cede/gr2.jpg

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