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SepsisPhase 4AGESNCT06712641

Aminoglycosides in Early Sepsis

A Phase 4 study testing Gentamicin + narrow spectrum betalactam, Cefotaxime and Piperacillin-tazobactam in people with Sepsis, run by University Hospital, Akershus at 15 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
Gentamicin + narrow spectrum betalactam, Cefotaxime and Piperacillin-tazobactam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,900 participants
Where
15 sitesNorway
Study dates
23 Apr 2026to May 2033
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Renal transplantation
  • Renal replacement therapy
  • Myasthenia gravis
  • Known hypersensitivity to any of the study drugs
  • Pregnancy

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Magnus N Lyngbakken, MD PhD contact

+4793408837

magnus.lyngbakken@medisin.uio.no

Kristian Tonby, MD PhD contact

+4741550565

kristian.tonby@medisin.uio.no

15 sites in 1 country

Norway15 sites, 15 recruiting

  • Ålesund Hospital, Helse Møre og Romsdal HF

    Ålesund

    Pascal Brügger-Synnes, MD, +4796507314, Pascal.Brugger-Synnes@helse-mr.no

    Not yet recruiting

  • Haukeland University Hospital

    Bergen, Bergen

    Oddvar Oppegaard, MD PhD, +47 97 58 57 09, oddvar.oppegaard@helse-bergen.no

    Recruiting

  • Bodø Hospital Nordlandssykehuset HF

    Bodø

    Ida Tveter, MD, +4747278252, Ida.Tveter@nordlandssykehuset.no

    Not yet recruiting

  • Drammen Hospital, Vestre Viken HF

    Drammen

    Lars Heggelund, MD PhD, +4748285882, Lars.Heggelund@vestreviken.no

    Not yet recruiting

  • Bærum Hospital, Vestre Viken Hospital Trust

    Gjettum

    Helene Hestmann, MD, +4741610490, HHESTM@vestreviken.no

    Not yet recruiting

  • Østfold Hospital Kalnes HF

    Grålum

    Øystein T Simonsen, MD PhD, +4741100059, Oystein.Simonsen@so-hf.no

    Not yet recruiting

  • Nordmøre and Romsdal Hospital, Helse Møre og Romsdal HF

    Hjelset

    Synnøve Berg, MD, +4771120000, synnove.underlid.berg@helse-mr.no

    Not yet recruiting

  • Ringerike Hospital, Vestre Viken Hospital Trust

    Hønefoss

    Caroline Hvitmyhr, MD, +4793433623, cargus@vestreviken.no

    Not yet recruiting

  • Akershus University Hospital

    Lørenskog, 1478

    Magnus N Lyngbakken, MD PhD, +4793408837, magnus.lyngbakken@medisin.uio.no

    Jan Erik Berdal, MD PhD, +4748205817, Jan-Erik.Berdal@ahus.no

    Recruiting

  • Lovisenberg Diakonal Hospital

    Oslo, Oslo

    Hedda Hoel, MD PhD, +47 90 15 58 28, HeddaBenedicte.Hoel@lds.no

    Recruiting

  • Oslo University Hospital Ullevål

    Oslo, 0450

    Kristian Tonby, MD PhD, +4741550565, kristian.tonby@medisin.uio.no

    Aleksander R Holten, MD PhD, +4799275784, aleksander.holten@gmail.com

    Recruiting

  • Sykehuset Telemark Skien

    Skien

    Jørn Einar Rasmussen, MD, +4735003500, Jorn.Einar.Rasmussen@sthf.no

    Not yet recruiting

  • Vestfold Hospital HF

    Tønsberg

    Øyvind M Hernes, MD, +4733342000, Oyvind.Misund.Hernes@siv.no

    Not yet recruiting

  • University Hospital of North Norway

    Tromsø

    Vegard Skogen, MD PhD, +4791364541, Vegard.Skogen@unn.no

    Not yet recruiting

  • St. Olav's Hospital

    Trondheim, Trondheim

    Birgitta Ehrnström, MD PhD, +47 45 51 10 37, birgitta.ehrnstrom@ntnu.no

    Not yet recruiting

Other trials in Norway

About this study

Official title: Aminoglycosides in Early Sepsis (AGES): A Randomized Pragmatic Clinical Trial Comparing Gentamicin and Narrow Spectrum Betalactams to Broad Spectrum Betalactams as Empirical Treatment in Patients With Suspected Sepsis

Norwegian guidelines for empirical antibiotic therapy in suspected community acquired sepsis recommend the combination of narrow spectrum betalactam and aminoglycoside as the first choice, but broad spectrum betalactams are considered equally appropriate, effective, and safe. However, fear of renal complications due to gentamicin and concern for lacking evidence for efficiency commonly leads to the use of broad spectrum betalactam therapy, a larger driver of antibiotic resistance.

In patients with suspected community acquired sepsis, the investigators hypothesize that empirical combination therapy with narrow spectrum betalactams and aminoglycosides is safe and non-inferior to empirical therapy with broad spectrum betalactams. More specifically, the investigators hypothesize that the proportion of patients with acute kidney injury or death will be similar between these two treatment groups. Furthermore, the investigators hypothesize that the aminoglycoside-based regimen has lesser impact on the gut microbiome. Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required but failed to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In this context, novel initiatives aiming at reducing use of antibiotics are direly needed.

Conditions
Sepsis
Being tested
Gentamicin + narrow spectrum betalactam, Cefotaxime, Piperacillin-tazobactam
Keywords
sepsis, antibiotics, aminoglycosides, cephalosporins
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gentamicin + narrow spectrum betalactamDrug

    Empirical therapy for suspected community-acquired sepsis with gentamicin + narrow spectrum betalactam (either one of penicillin, ampicillin, or cloxacillin)

  • CefotaximeDrug

    Empirical therapy for suspected community-acquired sepsis with cefotaxime

  • Piperacillin-tazobactamDrug

    Empirical therapy for suspected community-acquired sepsis with piperacillin-tazobactam

Study groups in NCT06712641
Study groupRoleWhat they receive
Gentamicin + narrow spectrum betalactamActive comparatorEmpirical therapy for suspected community-acquired sepsis with gentamicin + narrow spectrum betalactam (either one of penicillin, ampicillin, or cloxacillin)
Receives: Drug: Gentamicin + narrow spectrum betalactam
Cefotaxime or piperacillin-tazobactamActive comparatorEmpirical therapy for suspected community-acquired sepsis with broad spectrum betalactam (either one of cefotaxime or piperacillin-tazobactam)
Receives: Drug: Cefotaxime; Drug: Piperacillin-tazobactam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality

    All-cause mortality up to 30 days after randomization

    Measured: Up to 30 days after randomization

  2. 30-day acute kidney injury

    Any acute kidney injury up to 30 days after randomization

    Measured: Up to 30 days after randomization

Secondary outcomes (8)

  1. In-hospital mortality

    All-cause mortality during index hospitalization

    Measured: During index hospitalization (commonly up to 30 days)

  2. Duration of hospital stay

    Duration of index hospitalization (days)

    Measured: During index hospitalization (commonly up to 30 days)

  3. Duration of intensive care stay

    Duration of stay in intensive care unit (days)

    Measured: During index hospitalization (commonly up to 30 days)

  4. Duration of ventilator therapy

    Duration of therapy with invasive mechanical ventilation (days)

    Measured: During index hospitalization (commonly up to 30 days)

  5. Duration of vasopressor therapy

    Duration of therapy with vasoactive (vasopressor) (days)

    Measured: During index hospitalization (commonly up to 30 days)

  6. Hospital readmissions

    Readmission after discharge from index hospitalization

    Measured: Up to 30 days after discharge from index hospitalization

  7. Post-discharge mortality

    All-cause mortality after discharge from index hospitalization

    Measured: Up to 30 days after discharge from index hospitalization

  8. Duration of antibiotic treatment

    Duration of antibiotic therapy during index hospitalization (days of therapy, DOT)

    Measured: During index hospitalization (commonly up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start23 Apr 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionMay 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712641
Sponsor's protocol ID
2024-519797-39-00
Acronym
AGES
Status last verified
Oct 2026
First submitted
27 Nov 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The dataset used in this study is not publicly available, as the Data Protection Authority approval and patient consent do not allow for such publication. The study group welcomes initiatives for cooperation and data access may be granted upon application.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gentamicin + narrow spectrum betalactam, Cefotaxime and Piperacillin-tazobactam in people with Sepsis, run by University Hospital, Akershus at 15 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Magnus N Lyngbakken, MD PhD (+4793408837, magnus.lyngbakken@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality (time frame: Up to 30 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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