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

RecruitingNAAges 18 Years - anyAllDr Cipto Mangunkusumo General Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years. * Sepsis or septic shock according to Sepsis-3 criteria, defined as suspected or confirmed infection with acute organ dysfunction (SOFA score increase โ‰ฅ2 points from baseline) within 24 hours of inclusion. * Hospitalized at RSCM and undergoing microbiological testing, including blood culture as part of standard care. * At least one risk factor for multidrug-resistant (MDR) pathogens according to the 2026 Surviving Sepsis Campaign, including: * Previous colonization or infection with a relevant MDR pathogen. * Prolonged exposure to broad-spectrum antibiotics. * Prolonged hospitalization in a setting with a high prevalence of MDR pathogens, such as the ICU or a ward with a high antimicrobial resistance burden. * Written informed consent from the patient or legal representative, where applicable for prospective enrollment. Exclusion Criteria: * 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. Dropout criteria: \- Discharge from the hospital or death within 24 hours after blood collection.
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What it tests

  • Standard-of-care blood culture
  • Hybrispot DNA Flow
  • Metagenomic 16s RNA
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Where

1 site
Dr Cipto Mangunkusumo General Hospital
Jakarta, Indonesia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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