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临床试验/NCT06238297
NCT06238297招募中不适用

Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia (SNAP Study)

University of Bari Aldo Moro2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
76
试验地点
2
主要终点
Duration of antibiotic intake

研究概览

简要总结

The current IDSA/ATS guidelines recommend Linezolid and Vancomycin for MRSA coverage in hospitalized patients with pneumonia, which is common clinical practice in Italy. However, a nasal PCR-assay for MRSA has a high negative predictive value and can facilitate rapid antibiotic de-escalation, thereby avoiding unnecessary anti-MRSA treatments. The indiscriminate use of these drugs has contributed to the emergence of resistant S. aureus strains and has led to significant adverse effects, without providing any survival benefits. Additionally, it has increased hospital stays and associated costs. The proposed study aims to use this diagnostic tool to shorten empirical anti-MRSA treatment duration in pneumonia patients, focusing on reducing antimicrobial therapy days while measuring in-hospital mortality, length of stay and adverse drug event incidence.

详细描述

BACKGROUND On the basis of current IDSA/ATS guidelines antimicrobial agents such as Linezolid and Vancomycin are commonly used in hospitalized patients as an empirical treatment in community acquired pneumonias (CAPs) particularly in hospital-acquired pneumonias (HAPs) and ventilator associated pneumonias (VAPs), suggesting the empiric use of such anti-MRSA agents for patients with specific risk factors (e.g. recent hospitalization, exposure to parenteral antibiotics and/or previous isolation of these organisms, in particular from the respiratory tract) while obtaining culture data.

According to the 2023 annual report of the European Antibiotic Resistance Surveillance System (EARSS) there is a high prevalence of MRSA throughout the European territory, however, even in countries with high endemicity, the presence of MRSA has remained stable in the last years. In Italy, according to the National Antibiotic-Resistance Surveillance System AR-ISS, in 2021 the percentage of blood isolates MRSA isolates showed a reduction (29.9%) in the national territory, standing, however, at 33.6% in the Puglia region, a percentage higher than the European.

In patients with pneumonia, the nasal PCR-assay for MRSA has a high negative predictive value (NPV), with the crucial implication that a negative result can be used to guide the antibiotic de-escalation, avoiding an improper empiric use of the anti-MRSA therapy. Data supporting the clinical validity of the use of the nasal swab for MRSA as a diagnostic tool for pneumonia are robust, in this regard, as stated by the IDSA/ATS guidelines and supported by numerous retrospective studies, anti-MRSA treatment can be avoided in case of negative result, especially in non-severe CAP, thus preventing the misuse of anti-MRSA drugs.

The indiscriminate use of these drugs over time has considerably led to the selection of resistant strains of S. aureus such as Vancomycin-intermediate Staphylococcus aureus (VISA), heterogeneous VISA (hVISA) and Vancomycin-resistant Staphylococcus aureus (VRSA). Furthermore, the high risk of adverse events given by the empirical use of anti-MRSA drugs should also be noted including, among others, nephrotoxicity and ototoxicity with vancomycin and bone marrow suppression and peripheral neuropathy with linezolid, without a gain in terms of survival and with longer hospitalization stays.

In addition, the systematic use of such drugs is associated with an increase in hospital costs, where the PCR assay for MRSA has a relevant role. According to a study conducted by the Stanford University in 2021, enabling antibiotic de-escalation within 24h, its use has of facts led to a cost saving of vancomycin of $40.33 per patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects 18 years or older.
  • Patients hospitalized at the Azienda Consorziale Policlinico di Bari;
  • Clinical diagnosis of CAP/HAP/VAP;
  • Commitment by the prescribing physician to set an anti-MRSA antibiotic therapy in empirical
  • Enrollement within 48h from the beginning of the empirical anti-MRSA therapy.

排除标准

  • Febrile neutropenia or severe immunodeficiency;
  • Chronic airway infection (eg cystic fibrosis);
  • Suspect of extrapulmonary infection by MRSA
  • Refusal by the patient or legal guardian;
  • Refusal by the physician in charge of the patient to perform antibiotic de-escalation based on the result of the nasal swab;
  • Enrollment after 48 hours from the beginning of the empirical anti-MRSA therapy.

研究组 & 干预措施

Intervention

Experimental

Patients included into the intervention arm will undergo a nasal swab for MRSA and empirical anti-MRSA therapy will be discontinued f the nasal swab result is negative.

干预措施: MRSA nasal swab based de-escalation (Diagnostic Test)

Control

No Intervention

Patients randomized into the control arm will continue pneumonia treatment as per standard of care

结局指标

主要结局

Duration of antibiotic intake

时间窗: From day zero to day 28

次要结局

  • In-hospital mortality(From day zero to day 28)
  • Hospital lenght-of stay(From day zero to day 28 or until discharge)
  • Incidence of drug-related adverse outcomes(From day zero to day 28)
  • Hospital costs(From day zero to day 28 or until discharge)
  • Incidence of severe pneumonia requiring mechanical ventilation(From day zero to day 28 or until discharge)

研究者

发起方
University of Bari Aldo Moro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Vladimiro Segala

Principal investigator

University of Bari Aldo Moro

研究点 (2)

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