Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital
- Sepsis
- Antimicrobial Resistance (AMR)
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
- Enrolment target
- 415
- Started
- 1 September 2026
- Main results due
- 31 August 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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. * 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Dr Cipto Mangunkusumo General Hospital
Jakarta, DKI Jakarta, Indonesia
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07841535. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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