Rapid multiplex PCR test for bloodstream infections
Evaluation of the Clinical Efectiveness of a Multiplex PCR-Based Rapid Diagnostic Method in Bloodstream Infections: A Prospective Randomized Controlled Study
Istanbul Medipol University Hospital · NCT07408544
This project will test whether a rapid multiplex PCR test can identify pathogens and resistance genes faster than standard culture methods for hospitalized adults with positive blood cultures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul Medipol University Hospital (other) |
| Locations | 1 site (Istanbul, Bagcılar) |
| Trial ID | NCT07408544 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, controlled, single-center trial enrolling 300 adults with positive blood culture signals to compare a multiplex PCR-based rapid diagnostic method applied directly to positive blood culture bottles versus standard culture-based microbiology. Patients will be randomized to receive rapid PCR results or standard diagnostics, and clinicians will be able to use the information to guide antimicrobial therapy. Primary and secondary outcomes include diagnostic performance, time to optimal antimicrobial therapy, antimicrobial use patterns, and clinical outcomes such as length of stay and mortality. The study is conducted at Istanbul Medipol University Hospital and focuses on real-world clinical effectiveness in hospitalized wards and intensive care units.
Who should consider this trial
Good fit: Hospitalized adults (age ≥18) with clinical suspicion of bloodstream infection and a positive blood culture signal who can provide informed consent or have a legally authorized representative are eligible.
Not a fit: Patients with recurrent episodes of the same infection, inadequate or insufficient blood culture samples, death within 24 hours, loss to follow-up, or infections not covered by the PCR panel are unlikely to receive benefit from the intervention.
Why it matters
Potential benefit: If successful, the test could shorten time to targeted antibiotics, reduce unnecessary broad-spectrum drug use, and potentially lower complications and hospital length of stay.
How similar studies have performed: Prior studies and antimicrobial stewardship programs have shown that rapid molecular diagnostics from positive blood cultures can shorten time to identification and reduce broad-spectrum antibiotic use, although impacts on mortality have been variable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul, Bagcılar
- Istanbul Medipol University Hospital — Istanbul, Bagcılar, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Meyha Sahin — Medipol University
- Study coordinator: Meyha Sahin, Assoc. Prof. Dr.
- Email: meyha.sahin@medipol.edu.tr
- Phone: +905374505311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bloodstream Infections, Bacteremia and Sepsis, Fungemia, Bloodstream Infection, Rapid Diagnostic Test, Multiplex PCR, Molecular Diagnostics, Time to Optimal Therapy