Rapid multiplex PCR test for bloodstream infections
Official title: Evaluation of the Clinical Efectiveness of a Multiplex PCR-Based Rapid Diagnostic Method in Bloodstream Infections: A Prospective Randomized Controlled Study
Run by Istanbul Medipol University Hospital · NCT07408544 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Istanbul Medipol University Hospital Academic / other |
| Locations | 1 site (Istanbul, Bagcılar) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07408544 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.