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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway
Lovisenberg Diakonale Sykehus AS Oslo Norway
Universitetssykehuset Nord-Norge HF Tromsø Norway
Vestre Viken HF Drammen Norway
Nordlandssykehuset HF Bodo Norway
Sykehuset I Vestfold HF Tonsberg Norway
Ajtfijhq Uzygahwsmq Habmdcrz Lorenskog Norway
Hnpor Bizztn Hs Bergen Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
01.06.2025

Trial locations

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.

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 ID:
2024-519797-39-00
NCT ID:
NCT06712641
Trial Phase:
Therapeutic confirmatory (Phase III)

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