Study on Meropenem Dosing for Patients with Serious Infections in Intensive Care

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What is this study about?

This clinical trial is focused on treating serious infections that require broad-spectrum antibiotics. The study is examining the use of the antibiotic Meropenem, which is commonly used in hospitals to treat severe infections. The trial aims to find the best way to administer this medication to patients in the intensive care unit (ICU). Specifically, it compares two different dosing schedules: one where Meropenem is given in short infusions six times a day, and another where it is given in longer infusions three times a day.

The purpose of the study is to determine if the shorter, more frequent dosing is as effective as the longer, less frequent dosing. Participants in the study will receive one of these two dosing schedules while they are in the ICU. The study will monitor how well the medication works in maintaining adequate levels in the body, as well as other factors like the length of stay in the ICU and any serious side effects that may occur.

This trial is important for optimizing the treatment of serious infections in critically ill patients. By comparing these two dosing methods, the study hopes to improve the effectiveness of Meropenem and potentially enhance patient outcomes in the ICU setting. The study will run for a period of time, and results will be collected to assess which dosing schedule provides the best results for patients.

1 joining the study

Upon joining the study, the participant must be at least 18 years old and admitted to the intensive care unit with a confirmed or suspected serious infection.

The participant or their next of kin must provide informed consent to participate in the study. If the participant is unable to consent due to medical reasons, consent may be obtained from the next of kin.

2 treatment initiation

The treatment involves the administration of meropenem, a broad-spectrum antibiotic, for at least 3 days.

Participants will receive meropenem either as 1 gram infusions over 15 minutes, six times daily, or as 2 grams infusions over 3 hours, three times daily.

3 monitoring and assessment

The primary goal is to ensure that the concentration of meropenem in the blood remains above 2 mg/l for more than 50% of the time each day.

Participants will be monitored to assess the effectiveness of the dosing regimen over the course of 1, 2, and 3 days.

4 evaluation of outcomes

Secondary outcomes include the length of stay in the intensive care unit, mortality 30 days after admission, and any serious adverse events.

The study aims to determine if the more frequent, shorter infusions are as effective as the standard dosing regimen.

Who Can Join the Study?

  • Participants must be at least 18 years old to give their agreement to join the study.
  • The participant must be staying in the Intensive Care Unit at Oslo University Hospital, Rikshospitalet.
  • The participant must have a confirmed or suspected serious infection. This means an infection that is severe and requires strong antibiotics.
  • There must be a need for treatment with meropenem for at least 3 days. Meropenem is a type of strong antibiotic used to treat serious infections.
  • The patient or their family member must agree to participate in the study.
  • Both men and women can join the study. Women who can have children must use birth control or take a pregnancy test.
  • If the patient is awake and aware, they will be asked to agree to join the study. If the patient cannot agree because they are sedated or on a breathing machine, a family member will be asked for agreement, which can be delayed until the next day.

Who Cannot Join the Study?

  • Having a serious infection that requires treatment with a broad-spectrum antibiotic. This means an infection that is severe and needs strong antibiotics that can fight a wide range of bacteria.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

No sites found in this category

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

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
26.04.2021

Trial locations

Investigated drugs:

Meropenem is an antibiotic used to treat serious infections caused by bacteria. In this study, it is being tested to see if giving it in shorter, more frequent doses is as effective as the standard method of giving it in longer, less frequent doses. The goal is to find the best way to administer this medication to patients in the intensive care unit.

Investigated diseases:

Serious Infection Requiring Broad-Spectrum Antibiotic – This condition involves a severe infection that necessitates the use of broad-spectrum antibiotics to combat a wide range of bacteria. Such infections can occur in various parts of the body and may lead to significant health issues if not addressed promptly. The progression of the disease can vary depending on the type of bacteria involved and the individual’s overall health. Symptoms may include fever, chills, fatigue, and localized pain or swelling. The condition often requires hospitalization and close monitoring to ensure effective management.

Trial ID:
2024-520030-30-00
Protocol code:
Mer-6
NCT ID:
NCT05578586
Trial Phase:
Therapeutic confirmatory (Phase III)

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