Molecular tests to speed up sepsis microbe ID at Indonesia’s national referral hospital

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with sepsis or septic shock at Dr. Cipto Mangunkusumo General Hospital, researchers compare standard blood culture to two molecular methods—Hybrispot DNA Flow and metagenomic sequencing—to see which identifies pathogens fastest. They will measure how quickly each method provides results and how that timing might influence the start of targeted antimicrobial therapy and patient outcomes. The trial uses a standard-of-care design with these molecular tests added to routine diagnostic workflows. Here, turnaround time and potential clinical impact are the primary focus, with safety and feasibility assessed in the local setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dr Cipto Mangunkusumo General Hospital
  Jakarta, DKI Jakarta, Indonesia Recruiting

Study contacts

• Principal investigator: Robert Sinto, MD, MSc.Clin.Ed, D.Phil — Dr Cipto Mangunkusumo General Hospital
• Study coordinator: Robert Sinto, MD, MSc.Clin.Ed, D.Phil
• Email: robert.sinto01@ui.ac.id
• Phone: +628158835432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.