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Aminoglycosides in Early Sepsis

ConditionSepsis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gentamicin + narrow spectrum betalactam

    Drug

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

  • Cefotaxime

    Drug

    Empirical therapy for suspected community-acquired sepsis with cefotaxime

  • Piperacillin-tazobactam

    Drug

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

Treatment groups

1,900 Participants
are divided into 2 treatment groups
Group A: Gentamicin + narrow spectrum betalactamActive comparator 1 intervention
Group B: Cefotaxime or piperacillin-tazobactamActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

30-day mortality

All-cause mortality up to 30 days after randomization

Time frame
Up to 30 days after randomization
2

30-day acute kidney injury

Any acute kidney injury up to 30 days after randomization

Time frame
Up to 30 days after randomization

Secondary outcomes

1

In-hospital mortality

All-cause mortality during index hospitalization

Time frame
During index hospitalization (commonly up to 30 days)
2

Duration of hospital stay

Duration of index hospitalization (days)

Time frame
During index hospitalization (commonly up to 30 days)
3

Duration of intensive care stay

Duration of stay in intensive care unit (days)

Time frame
During index hospitalization (commonly up to 30 days)
4

Duration of ventilator therapy

Duration of therapy with invasive mechanical ventilation (days)

Time frame
During index hospitalization (commonly up to 30 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Akershus

Lead sponsor

Ullevaal University Hospital

Collaborator

Source ClinicalTrials.gov
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