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

NCT06238297 | Recruiting

• 1 other identifier: SNAPv1.2
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia, Bacterial

Keywords

MRSA; Antimicrobial stewardship; Randomized trial; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Duration of antibiotic intake

  From day zero to day 28

Secondary Outcomes (5)

• In-hospital mortality

  From day zero to day 28

• Hospital lenght-of stay

  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

• Incidence of drug-related adverse outcomes

  From day zero to day 28

• Hospital costs

  From day zero to day 28 or until discharge

Study Arms (2)

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.

Diagnostic Test: MRSA nasal swab based de-escalation

Control

NO INTERVENTION

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

Interventions

MRSA nasal swab based de-escalation DIAGNOSTIC_TEST

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari Aldo Moro: lead

Study Sites (1)

Università di Bari "Aldo Moro"

Bari, 70124, Italy

RECRUITING

Related Publications (7)

• Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.

  PMID: 31573350 BACKGROUND

• Dangerfield B, Chung A, Webb B, Seville MT. Predictive value of methicillin-resistant Staphylococcus aureus (MRSA) nasal swab PCR assay for MRSA pneumonia. Antimicrob Agents Chemother. 2014;58(2):859-64. doi: 10.1128/AAC.01805-13. Epub 2013 Nov 25.

  PMID: 24277023 BACKGROUND

• Parente DM, Cunha CB, Mylonakis E, Timbrook TT. The Clinical Utility of Methicillin-Resistant Staphylococcus aureus (MRSA) Nasal Screening to Rule Out MRSA Pneumonia: A Diagnostic Meta-analysis With Antimicrobial Stewardship Implications. Clin Infect Dis. 2018 Jun 18;67(1):1-7. doi: 10.1093/cid/ciy024.

  PMID: 29340593 BACKGROUND

• Mergenhagen KA, Starr KE, Wattengel BA, Lesse AJ, Sumon Z, Sellick JA. Determining the Utility of Methicillin-Resistant Staphylococcus aureus Nares Screening in Antimicrobial Stewardship. Clin Infect Dis. 2020 Aug 22;71(5):1142-1148. doi: 10.1093/cid/ciz974.

  PMID: 31573026 BACKGROUND

• Dadgostar P. Antimicrobial Resistance: Implications and Costs. Infect Drug Resist. 2019 Dec 20;12:3903-3910. doi: 10.2147/IDR.S234610. eCollection 2019.

  PMID: 31908502 BACKGROUND

• Meng L, Pourali S, Hitchcock MM, Ha DR, Mui E, Alegria W, Fox E, Diep C, Swayngim R, Chang A, Banaei N, Deresinski S, Holubar M. Discontinuation Patterns and Cost Avoidance of a Pharmacist-Driven Methicillin-Resistant Staphylococcus aureus Nasal Polymerase Chain Reaction Testing Protocol for De-escalation of Empiric Vancomycin for Suspected Pneumonia. Open Forum Infect Dis. 2021 Mar 4;8(4):ofab099. doi: 10.1093/ofid/ofab099. eCollection 2021 Apr.

  PMID: 34386545 BACKGROUND

• De Vita E, Segala FV, Cavallin F, Guido G, Frallonardo L, Cotugno S, Pellegrino C, Di Gennaro F, Saracino A. 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). Front Med (Lausanne). 2024 Sep 10;11:1416904. doi: 10.3389/fmed.2024.1416904. eCollection 2024.

  PMID: 39318595 DERIVED

Related Links

• Antimicrobial resistance surveillance in Europe - 2023
• Rapporto AR-ISS - I dati 2022 - Istituto Superiore di Sanità

MeSH Terms

Conditions

Pneumonia, Bacterial; Pneumonia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: May 6, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

IT (1)