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RECRUITING
NCT07841535
NA

Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital

Sponsor: Dr Cipto Mangunkusumo General Hospital

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Hybrispot DNA Flow

Hybrispot DNA Flow is a diagnostic tool combining multiplex polymerase chain reaction (PCR) and flow-through hybridization.

DIAGNOSTIC_TEST

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