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Can molecular tests outpace blood culture in the race to identify deadly sepsis pathogens?

NCT ID NCT07841535

Diagnosis Sponsor: Dr Cipto Mangunkusumo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers at an Indonesian national referral hospital are comparing standard blood culture with two molecular diagnostic methods, Hybrispot DNA Flow and metagenomic 16S rRNA sequencing, for identifying microorganisms in patients with sepsis. The study enrolls 415 adults with sepsis or septic shock who have risk factors for multidrug-resistant infections. The goal is to see whether molecular tests can provide pathogen results faster than blood culture and whether that speed helps doctors start the right antibiotics sooner and improve outcomes like survival and hospital stay length.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
molecular diagnostic tests (Hybrispot DNA Flow and metagenomic 16S rRNA sequencing) compared with standard blood culture
What this could lead to
If molecular tests identify sepsis pathogens faster than standard blood culture, hospitals could start targeted antibiotics sooner, which may improve survival and slow antibiotic resistance.
What could go wrong
The molecular tests may detect genetic material from organisms that are not actually causing the infection, leading to unnecessary treatment. They may also miss pathogens that blood culture would catch, and faster results do not always translate into better patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 415 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antimicrobial resistance (AMR) Sepsis

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Dr Cipto Mangunkusumo General Hospital

    RECRUITING

    Jakarta, DKI Jakarta, 10430, Indonesia

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