Actively Recruiting
Evaluation of the Clinical Effectiveness of a Multiplex PCR-Based Rapid Diagnostic Method in Bloodstream Infections: A Prospective Randomized Controlled Study
Led by Istanbul Medipol University Hospital · Updated on 2026-02-13
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Bloodstream infections are serious infections that can lead to high rates of sickness and death. Early and appropriate antimicrobial treatment is crucial for survival, but standard culture methods to identify the infection and its resistance patterns take 24 to 72 hours, often delaying targeted therapy. This trial evaluates whether a rapid multiplex PCR diagnostic test, which can identify pathogens and resistance genes within about one hour, improves treatment timing and patient outcomes compared to conventional methods in adults with bloodstream infections. The study is a prospective, randomized, controlled clinical trial enrolling 300 adults aged 18 and older with positive blood culture signals. Participants are randomly assigned to either a group that receives both standard microbiological diagnostics and the rapid multiplex PCR test or a control group that receives standard diagnostics alone. The PCR test is applied directly to positive blood culture bottles and results are reported within an hour to guide antimicrobial therapy decisions. The control group follows routine laboratory methods including Gram staining, culture, organism identification, and susceptibility testing. Participants will be monitored throughout their hospital stay, up to 28 days, with data collected on antimicrobial therapy timing, pathogen identification, treatment adjustments, hospital length of stay, and mortality. Clinical and demographic information, including severity scores and comorbidities, will be recorded. The study will measure primary outcomes such as time to optimal antimicrobial therapy and secondary outcomes like time to pathogen identification and therapy changes. The diagnostic accuracy of the PCR test will also be compared to standard culture methods.
CONDITIONS
Brief Title
Clinical Efectiveness of a Multiplex PCR-Based Rapid Diagnostic Method in Bloodstream Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During hospitalization, up to 28 days
Participants with positive blood culture signals undergo diagnostic testing using either rapid multiplex PCR and standard microbiological methods or standard microbiological methods alone to identify bloodstream infection pathogens and antimicrobial resistance genes.
Testing performed as blood culture signals positive; timing depends on clinical workflow
Duration - Through hospitalization, up to 28 days
Participants are monitored through hospitalization and up to 28 days to assess antimicrobial therapy optimization, treatment outcomes, and survival.
Ongoing clinical assessments during hospital stay
Trial Site Locations
Total: 1 location
1
Istanbul Medipol University Hospital
Istanbul, Bagcılar, Turkey (Türkiye), 34218
Actively Recruiting
Research Team
M
Meyha Sahin, Assoc. Prof. Dr.
M
Mehmet Emre Tekinsen, Medical Student
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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