NCT07841535 Molecular-based Optimization of Pathogen Identification in Sepsis Patients in the Indonesian National Referral Hospital
| NCT ID | NCT07841535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr Cipto Mangunkusumo General Hospital |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 415 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 415 participants in total. It began in 2026-09-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Robert Sinto, MD, MSc.Clin.Ed, D.Phil
PRINCIPAL INVESTIGATOR
Dr Cipto Mangunkusumo General Hospital
Frequently Asked Questions
Who can join the NCT07841535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07841535 currently recruiting?
Yes, NCT07841535 is actively recruiting participants. Contact the research team at robert.sinto01@ui.ac.id for enrollment information.
Where is the NCT07841535 trial being conducted?
This trial is being conducted at Jakarta, Indonesia.
Who is sponsoring the NCT07841535 clinical trial?
NCT07841535 is sponsored by Dr Cipto Mangunkusumo General Hospital. The principal investigator is Robert Sinto, MD, MSc.Clin.Ed, D.Phil at Dr Cipto Mangunkusumo General Hospital. The trial plans to enroll 415 participants.