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Clinical Efectiveness of a Multiplex PCR-Based Rapid Diagnostic Method in Bloodstream Infections

Recruitingn/aAges 18 Years - anyAllIstanbul Medipol University Hospital
NCT07408544 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Bloodstream infections (BSIs) are associated with high morbidity and mortality, and delays in initiating appropriate antimicrobial therapy significantly worsen clinical outcomes. Conventional culture-based microbiological methods require 24-72 hours to provide definitive pathogen identification and antimicrobial susceptibility results, often leading to prolonged use of broad-spectrum empirical therapy. Rapid multiplex PCR-based diagnostic tests have the potential to shorten diagnostic timelines by identifying pathogens and resistance genes within approximately one hour; however, data on their real-world clinical impact remain limited. This prospective, randomized, controlled, single-center study aims to evaluate the clinical effectiveness and diagnostic performance of a multiplex PCR-based rapid diagnostic method applied directly to positive blood culture bottles in adult patients with

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Clinical suspicion of bloodstream infection * Positive blood culture signal * Patients managed in hospital wards or intensive care units * Ability to provide informed consent (patient or legally authorized representative) Exclusion Criteria: * Recurrent episode of the same bloodstream infection * Inadequate or insufficient blood culture sample for analysis * Refusal or inability to provide informed consent * Death within the first 24 hours after blood culture collection * Loss to follow-up during the study period
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What it tests

  • Multiplex PCR-Based Rapid Diagnostic Test
  • Standard Microbiological Diagnostic Methods
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Where

1 site
Istanbul Medipol University Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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