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STUDY PROTOCOL article
Front. Med.
Sec. Infectious Diseases: Pathogenesis and Therapy
Volume 11 - 2024 |
doi: 10.3389/fmed.2024.1416904
This article is part of the Research Topic Outbreak Investigations of Nosocomial Infections View all articles
Rapid de-escalation of anti-MRSA therapy guided by S. aureus nares screening for patients with pneumonia: protocol of a randomized controlled trial (SNAP study)
Provisionally accepted- 1 University of Bari Aldo Moro, Bari, Italy
- 2 Other, Solagna, Italy
INTRODUCTION The current Infectious Disease Society of America and American Thoracic Society (IDSA/ATS) guidelines recommend linezolid or vancomycin as an empiric treatment for methicillin-resistant Staphylococcus aureus (MRSA) pneumonia in hospitalized patients with specific risk factors. A nasal PCR-assay for MRSA, with its high negative predictive value, can guide a rapid antibiotic de-escalation avoiding unnecessary anti-MRSA treatment. The indiscriminate use of these drugs has contributed to the emergence of resistant S. aureus strains leading to adverse effects without any survival benefit, increasing hospital stays and associated costs. Aim of the study is the use of this diagnostic tool to reduce empirical anti-MRSA treatment duration in pneumonia, shortening antimicrobial therapy days while measuring in-hospital mortality, length of stay and adverse drug event incidence. METHODS It is a prospective, randomized single-center controlled trial planned to be conducted in the Azienda Consorziale Policlinico di Bari. The research project will have a duration of 12 months following the approval of the Ethical Committee of the University of Bari. The minimum sample size is 38 patients per group, for a total of 76 subjects, calculated assuming a standard deviation of 10, a power of 90%, a type I error of 5% and a 10% drop-out rate. We will enroll eligible patients ensuring their evidence-based management according to guidelines, we will perform a nasal swab for MRSA in patients in the experimental group and discontinue the empirical anti-MRSA therapy if the nasal swab result is negative. For both arms, follow-up visits will be on day 2, 5, 7, 14, and 28 relatives to the enrollment visit (day 0). Data will be collected on the clinical course of pneumonia and laboratory tests. DISCUSSION Our study will provide evidence on the duration (in days) of the antibiotic intake as a primary outcome of the study. Secondary outcome measures include in-hospital mortality, the length of stay and days of mechanical ventilation (in VAP), and the incidence of adverse events related to the administration of the therapy. Trial Registration ClinicalTrials.gov Identifier: NCT06238297. Registered February 2, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT06238297
Keywords: Methicillin-Resistant Staphylococcus aureus, Pneumonia, Clinical Trial, Antimicrobial stewardship, PCR-assay, protocol
Received: 13 Apr 2024; Accepted: 13 Aug 2024.
Copyright: © 2024 De Vita, Segala, Cavallin, Guido, Frallonardo, Cotugno, Pellegrino, Di Gennaro and Saracino. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Elda De Vita, University of Bari Aldo Moro, Bari, Italy
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