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Comparison of Gentamicin with Narrow-Spectrum Antibiotics versus Broad-Spectrum Antibiotics in Adult Patients with Early Sepsis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with suspected sepsis, a serious condition where the body's response to infection causes injury to its own tissues. The study compares two different antibiotic treatment approaches. The first approach combines narrow-spectrum antibiotics (penicillin, ampicillin, or cloxacillin) with gentamicin. The second approach uses broad-spectrum antibiotics (cefotaxime or piperacillin-tazobactam).

The purpose of this study is to determine if using a combination of narrow-spectrum antibiotics with gentamicin is as safe and effective as using broad-spectrum antibiotics alone in treating community-acquired sepsis. All medications in the study are given through an intravenous route, which means they are administered directly into the vein.

Participants in the study will receive one of these treatment approaches for up to three days. During and after treatment, doctors will monitor patients' health status, including how well their kidneys are working and their overall recovery. The study will track various aspects of patient recovery, including time spent in the hospital and need for additional treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your condition will be assessed using the National Early Warning Score 2 (NEWS2) to confirm if you meet the study criteria

    Your doctor will confirm if you have signs of suspected community acquired sepsis (a serious infection that started outside the hospital)

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of two antibiotic treatment options:

    Option 1: A combination of a narrow spectrum antibiotic (penicillin, ampicillin, or cloxacillin) with gentamicin

    Option 2: A broad spectrum antibiotic (cefotaxime or piperacillin-tazobactam)

  3. Step 3

    Treatment administration

    Your assigned antibiotics will be given through an intravenous line (directly into your vein)

    The treatment duration will be determined by your medical condition and response

  4. Step 4

    Monitoring period - first 30 days

    Your kidney function will be monitored for any signs of problems

    Your overall health status will be regularly checked

    The length of your hospital stay will be recorded

    If needed, any intensive care stay, breathing support, or blood pressure medication use will be documented

  5. Step 5

    Follow-up period

    After hospital discharge, your health status will continue to be monitored for 30 days

    Any hospital readmissions during this period will be recorded

Who can join the trial?

6 criteria

  • You must be 18 years or older
  • You must be currently admitted to the hospital
  • Your doctor must suspect you have sepsis that started outside the hospital and believe you need antibiotic treatment
  • You must have a NEWS2 score of 5 or higher (NEWS2 is a scoring system used by medical staff to measure how sick a patient is by checking things like breathing rate, blood pressure, and temperature)
  • You must be able to understand and sign an informed consent form that explains the study details and your rights as a participant
  • You can be either male or female

Who cannot join the trial?

12 criteria

  • Age under 18 years or over 65 years old
  • Known allergy or severe reaction to penicillin, ampicillin, cloxacillin, gentamicin, cefotaxime, or piperacillin-tazobactam (types of antibiotics used in the study)
  • Pregnancy or breastfeeding
  • Severe kidney problems (as some antibiotics used in the study may affect kidney function)
  • Hospital-acquired infections (infections that developed while staying in the hospital)
  • Already receiving antibiotic treatment for current infection
  • Severe hearing problems (as some antibiotics may affect hearing)
  • History of resistant bacteria infections (bacteria that don't respond to common antibiotics)
  • Severe liver disease
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Life-threatening conditions requiring immediate intensive care
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Investigated drugs

  • Gentamicin

    is an antibiotic medication used to treat various bacterial infections. It belongs to the aminoglycoside class of antibiotics and is particularly effective against certain types of bacteria. In this trial, it is used in combination with other antibiotics for treating suspected sepsis.

  • Penicillin

    is a narrow-spectrum antibiotic that fights bacteria in the body. It is one of the oldest and most widely used antibiotics, effective against many common bacterial infections.

  • Ampicillin

    is a narrow-spectrum antibiotic in the penicillin group. It works by stopping the growth of bacteria and is used to treat various bacterial infections.

  • Cloxacillin

    is a narrow-spectrum antibiotic that belongs to the penicillin family. It is particularly effective against certain types of bacteria that have become resistant to regular penicillin.

  • Cefotaxime

    is a broad-spectrum antibiotic that belongs to the cephalosporin family. It is used to treat various serious bacterial infections and works by preventing bacteria from forming their cell walls.

  • Piperacillin-tazobactam

    is a combination broad-spectrum antibiotic. Piperacillin kills bacteria, while tazobactam helps prevent bacterial resistance to piperacillin. This combination is used to treat serious bacterial infections.

What is already known about the treatment

  • Gentamicin

    An aminoglycoside antibiotic administered through injection or intravenous infusion, widely used in clinical practice for treating severe bacterial infections, particularly in cases of sepsis. This medication works by binding to bacterial ribosomes and interrupting protein synthesis, leading to bacterial cell death, and is particularly effective against gram-negative organisms. It belongs to the aminoglycoside class of antibiotics and is often used in combination with other antibiotics for synergistic effects.

  • Penicillin

    A narrow-spectrum beta-lactam antibiotic available in oral and injectable forms, recognized as one of the first discovered antibiotics and still widely used in modern medicine. It works by interfering with bacterial cell wall synthesis, causing bacterial cell death, and is particularly effective against gram-positive organisms. This medication belongs to the beta-lactam family of antibiotics and is commonly used for treating various bacterial infections, including some cases of sepsis when combined with other antibiotics.

  • Ampicillin

    A broad-spectrum penicillin antibiotic that can be administered orally or through injection, commonly used in clinical practice for various bacterial infections. It functions by preventing bacterial cell wall formation, leading to cell death, and is effective against both gram-positive and some gram-negative bacteria. This medication is classified as an aminopenicillin and is frequently used in combination therapy for treating serious infections, including sepsis.

  • Cloxacillin

    A penicillinase-resistant penicillin antibiotic available in oral and injectable forms, specifically designed to treat infections caused by penicillin-resistant bacteria. It works by interfering with bacterial cell wall synthesis and is particularly effective against staphylococcal infections. This medication belongs to the beta-lactam family of antibiotics and is commonly used in combination therapy for treating severe bacterial infections.

  • Cefotaxime

    A third-generation cephalosporin antibiotic administered through injection or intravenous infusion, widely used in modern medicine for treating serious bacterial infections. It works by disrupting bacterial cell wall synthesis and provides broad-spectrum coverage against many gram-positive and gram-negative bacteria. This medication belongs to the cephalosporin class of antibiotics and is commonly used as empirical treatment for suspected sepsis.

  • Piperacillin-tazobactam

    A combination antibiotic consisting of an extended-spectrum penicillin (piperacillin) and a beta-lactamase inhibitor (tazobactam), administered intravenously for serious bacterial infections. This combination provides very broad antimicrobial coverage while protecting against bacterial resistance mechanisms, making it particularly effective for treating severe infections including sepsis. It belongs to the beta-lactam/beta-lactamase inhibitor class of antibiotics and is commonly used in hospital settings for empirical treatment of severe infections.

Investigated diseases

Sepsis - A serious condition that occurs when the body's response to infection causes widespread inflammation throughout the body. It begins when germs get into the bloodstream and trigger an overactive immune response. This condition can develop from various types of infections including those in the lungs, urinary tract, abdomen, or other parts of the body. The immune system's response can lead to changes that can damage multiple organ systems. Sepsis typically starts with symptoms like fever, increased heart rate, and rapid breathing. The condition can progress rapidly if the initial infection is not controlled.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519797-39-00Estimated enrolment2 000 patientsSponsorAkershus University Hospital

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