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Can an older antibiotic combo fight sepsis and superbugs?

NCT ID NCT06712641

Disease control Sponsor: University Hospital, Akershus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of gentamicin and a narrow-spectrum antibiotic works as well as broad-spectrum antibiotics for early sepsis, with less impact on antibiotic resistance. About 1,900 adults with suspected community-acquired sepsis will be randomly assigned to one of three treatments. The main goals are to compare rates of death and kidney injury within 30 days.

What this could mean

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

Active substance
gentamicin, narrow spectrum betalactams (penicillin, ampicillin, or cloxacillin), cefotaxime, piperacillin-tazobactam
What this could lead to
If successful, this could show that a gentamicin-based combo is a safe, effective alternative that reduces antibiotic resistance in sepsis care.
What could go wrong
This is a Phase 4 trial, but results may not apply to severe sepsis cases. Gentamicin carries a known risk of kidney injury, and the study is limited to community-acquired sepsis.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,900 people

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

Started

Apr 2026

Expected to finish

May 2033

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: * Hospitalized * Adults 18 year or older * Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy * National Early Warning Score 2 (NEWS2) ≥ 5 * Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations Exclusion Criteria: * Established chronic kidney failure (eGFR \< 30 ml/min/1.73m2) * Presentation with septic shock with multiorgan failure * Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection) * Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months) * Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or other drug-resistant microbes necessitating specific antimicrobial therapy * Multiple myeloma * Renal transplantation * Renal replacement therapy * Myasthenia gravis * Known hypersensitivity to any of the study drugs * Pregnancy

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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.

Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akershus University Hospital

    RECRUITING

    Lørenskog, 1478, Norway

  • Haukeland University Hospital

    NOT_YET_RECRUITING

    Bergen, Bergen, Norway

  • Lovisenberg Diakonal Hospital

    NOT_YET_RECRUITING

    Oslo, Oslo, Norway

  • Oslo University Hospital Ullevål

    RECRUITING

    Oslo, 0450, Norway

  • St. Olav's Hospital

    NOT_YET_RECRUITING

    Trondheim, Trondheim, Norway

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