This study aims to compare the diagnostic performance of conventional blood culture with two molecular-based diagnostic approaches, Hybrispot DNA Flow and metagenomic next-generation sequencing (mNGS), for the identification of microorganisms in patients with sepsis. The study will evaluate the turnaround time of each diagnostic method and assess their potential impact on the time to definitive antimicrobial therapy and subsequent clinical outcomes.
The study is led by Robert Sinto, an infectious disease physician at Dr. Cipto Mangunkusumo National Referral Hospital (RSCM), the national referral hospital in Indonesia.
Conventional blood culture, which serves as the standard microbiological diagnostic method, may require about 5 to 7 days to obtain a final result. In comparison, Hybrispot DNA Flow and mNGS detect microbial genetic material and may provide microbiological results within approximately 2 to 3 days. By comparing these diagnostic strategies, the study seeks to determine whether molecular-based approaches can facilitate more rapid pathogen identification and support earlier optimization of antimicrobial therapy.
Participation in the study is voluntary. Participants may withdraw from the study at any time without affecting the medical care they receive. Participants may also request information about their diagnostic results and may ask the research team to clarify any aspect of the study that they do not understand.
Age ≥18 years.
Sepsis or septic shock according to Sepsis-3 criteria, defined as suspected or confirmed infection with acute organ dysfunction (SOFA score increase ≥2 points from baseline) within 24 hours of inclusion.
Hospitalized at RSCM and undergoing microbiological testing, including blood culture as part of standard care.
Previous colonization or infection with a relevant MDR pathogen.
Unable to provide specimens according to the study protocol.
Received intravenous antimicrobial regimen for more than 24 hours prior to study enrollment, with the regimen continued as empirical therapy for the current sepsis diagnosis.
Opt out of best treatment according to medical advice.
Parallel
Standard-of-care blood culture
Diagnostic testParticipants will undergo standard blood culture using the BACT/ALERT system. Cultures will be monitored until a final result of either microbial growth or no growth is obtained.
Hybrispot DNA Flow
Diagnostic testHybrispot DNA Flow is a diagnostic tool combining multiplex polymerase chain reaction (PCR) and flow-through hybridization.
Metagenomic 16s RNA
Diagnostic testThe metagenomic approach using the 16S rRNA platform enables comprehensive identification of microorganisms, including fastidious bacteria, low-abundance microorganisms, and unexpected or previously unrecognized pathogens.
All-cause mortality
Length of hospital stay
Time in days from day of sepsis diagnosis to actual hospital discharge
Diagnostic turnaround time
Time in hours needed from sample collection until the availability of the diagnostic result
Duration of antimicrobial therapy
Time in days from initiation of antimicrobial therapy indicated for sepsis during hospital stay until discontinuation of antimicrobial therapy
Time from empirical antimicrobial therapy to definitive therapy
Time in days from empirical antimicrobial therapy initiation to definitive therapy initiation
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