Condition: Bloodstream Infections · Bacteremia and Sepsis · Fungemia · Sponsor: Istanbul Medipol University Hospital
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 bloodstream infections. A total of 300 patients (≥18 years) with positive blood culture signals will be randomized 1:1 to either a study group or a control group. In the study group, positive blood cultures will be analyzed using both standard microbiological methods and a multiplex PCR panel, while the control group will undergo standard microbiological diagnostics alone. The primary endpoint is time to optimal antimicrobial therapy (OTT), defined as the time from blood culture collection to initiation of the narrowest-spectrum, guideline-recommended antimicrobial agent active against the id…
This description comes directly from the study's public registry record.
Meyha Sahin, Assoc. Prof. Dr. · +905374505311 · meyha.sahin@medipol.edu.tr
Mehmet Emre Tekinsen, Medical Student · +905454753281 · mehmet.tekinsen@std.medipol.edu.tr
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| Istanbul Medipol University Hospital | Istanbul, Bagcılar, Turkey (Türkiye) | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07408544