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Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital
Sponsor: Dr Cipto Mangunkusumo General Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
415
Start Date
2026-09-01
Completion Date
2027-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Standard-of-care blood culture
Participants 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
Hybrispot DNA Flow is a diagnostic tool combining multiplex polymerase chain reaction (PCR) and flow-through hybridization.
Metagenomic 16s RNA
The metagenomic approach using the 16S rRNA platform enables comprehensive identification of microorganisms, including fastidious bacteria, low-abundance microorganisms, and unexpected or previously unrecognized pathogens.
Locations (1)
Dr Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, Indonesia