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

NCT07408544 | Recruiting

• 1 other identifier: E-66291034-202.3.02-8843
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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 identified pathogen. Secondary endpoints include time to effective antimicrobial therapy (ETT), time to pathogen identification, antimicrobial escalation or de-escalation rates, length of hospital stay, total duration of antimicrobial therapy, and 28-day all-cause mortality. Clinical, demographic, and microbiological data will be collected prospectively, including comorbidity indices and severity scores. Randomization will be stratified by ICU versus ward admission, presence of neutropenia, and Charlson Comorbidity Index to ensure balanced groups. Diagnostic accuracy of the multiplex PCR panel will be assessed by calculating sensitivity, specificity, predictive values, and agreement with standard culture methods. This study seeks to determine whether rapid multiplex PCR diagnostics can meaningfully improve antimicrobial stewardship and clinical outcomes in patients with bloodstream infections compared with conventional diagnostic workflows.

Conditions

Bloodstream Infections; Bacteremia and Sepsis; Fungemia

Keywords

Bloodstream Infection; Rapid Diagnostic Test; Multiplex PCR; Molecular Diagnostics; Time to Optimal Therapy

Outcome Measures

Primary Outcomes (1)

• Time to Optimal Antimicrobial Therapy

  Time from blood culture collection to administration of the first dose of the narrowest-spectrum, guideline-recommended first-line antimicrobial therapy active against the isolated microorganism.

  Through hospitalization, up to 28 days

Secondary Outcomes (4)

• Time to Pathogen Identification (TPI)

  Through hospitalization, up to 28 days

• Time to Pathogen and Resistance Gene Identification (PRGI)

  Through hospitalization, up to 28 days

• Time to Rapid Antimicrobial Susceptibility Testing (RAST)

  Through hospitalization, up to 28 days

• Time to Definitive Antimicrobial Susceptibility Testing (AST)

  Through hospitalization, up to 28 days

Study Arms (2)

Multiplex PCR Group

Participants with positive blood culture signals undergo rapid multiplex PCR testing in addition to standard microbiological diagnostic methods. Results of the multiplex PCR assay are reported to the clinical team and may be used to guide antimicrobial management.

Diagnostic Test: Multiplex PCR-Based Rapid Diagnostic Test; Diagnostic Test: Standard Microbiological Diagnostic Methods

Standard Diagnostics Group

Participants with positive blood culture signals receive standard microbiological diagnostic testing only, according to routine clinical practice.

Diagnostic Test: Standard Microbiological Diagnostic Methods

Interventions

Multiplex PCR-Based Rapid Diagnostic Test DIAGNOSTIC_TEST

The intervention consists of a real-time multiplex polymerase chain reaction (PCR)-based in vitro diagnostic test applied directly to positive blood culture bottles. Following detection of a positive blood culture signal, an aliquot of the sample is processed for rapid nucleic acid extraction and analyzed using a multiplex PCR panel designed to identify predefined bacterial and fungal pathogens and selected antimicrobial resistance genes. Test results are available within approximately one hour and are reported to the treating clinical team. The multiplex PCR results may be used to inform antimicrobial treatment decisions, including escalation, de-escalation, or optimization of therapy, in conjunction with standard microbiological findings.

Multiplex PCR Group

Standard Microbiological Diagnostic Methods DIAGNOSTIC_TEST

Standard microbiological diagnostics include routine processing of positive blood cultures according to institutional practice. This consists of Gram staining, subculture on appropriate agar media, organism identification using conventional and automated methods, and antimicrobial susceptibility testing performed using standardized techniques. Results are reported to the clinical team as they become available and guide antimicrobial management according to usual care.

Multiplex PCR Group; Standard Diagnostics Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult hospitalized patients (≥18 years of age) with clinical suspicion of bloodstream infection and a confirmed positive blood culture signal. Eligible participants are recruited from medical and surgical wards as well as intensive care units of a tertiary university hospital. Patients with various underlying comorbid conditions, including immunosuppression and malignancy, are included in order to reflect real-world clinical practice. Only patients with a first episode of bloodstream infection during the study period are eligible for enrollment.

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcılar, 34218, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sepsis; Bacteremia; Fungemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Invasive Fungal Infections; Mycoses

Study Officials

• Meyha Sahin

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meyha Sahin, Assoc. Prof. Dr.

CONTACT

+905374505311; meyha.sahin@medipol.edu.tr

Mehmet Emre Tekinsen, Medical Student

CONTACT

+905454753281; mehmet.tekinsen@std.medipol.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)