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Life sciences · Interventional Study
ClinicalTrials.gov · September 25, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07841535). This is a study registration, not published results. Lead sponsor: Dr Cipto Mangunkusumo General Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 415 participants (ESTIMATED). Conditions: Sepsis, Antimicrobial Resistance (AMR). Interventions: DIAGNOSTIC_TEST: Standard-of-care blood culture; DIAGNOSTIC_TEST: Hybrispot DNA Flow; DIAGNOSTIC_TEST: Metagenomic 16s RNA. Primary outcome measures: All-cause mortality , 28 days after study enrollment. Brief 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.