Study Comparing Meropenem and Piperacillin/Tazobactam for Adults with Sepsis

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What is this study about?

This clinical trial is focused on studying the effects of two different treatments for adults with sepsis, a serious condition that occurs when the body has an extreme response to an infection. The study will compare the use of Meropenem Fresenius Kabi, a medication given as a solution for injection or infusion, with Piperacillin/Tazobactam Fresenius Kabi, which is also administered as a solution for infusion. Both medications are used to treat severe infections and are given through a vein.

The purpose of the study is to assess how these treatments affect the survival and other important health outcomes of critically ill adults with sepsis. Participants in the study will receive either Meropenem or Piperacillin/Tazobactam, and their health will be monitored over a period of time to see how they respond to the treatment. The study will look at various outcomes, including the number of days patients are alive without needing life support, the number of days they spend out of the hospital, and their overall quality of life.

The trial will also track any serious side effects that may occur, such as allergic reactions or infections, and will evaluate the presence of any resistant bacteria. The study aims to provide valuable information on which treatment may be more effective for patients with sepsis, ultimately helping to improve care for those affected by this life-threatening condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older) and a diagnosis of sepsis or septic shock.

The condition must be defined according to the Sepsis-3 criteria, which includes a suspected or documented infection and an acute increase of 2 or more points in the Sequential Organ Failure Assessment (SOFA) score, indicating acute organ dysfunction.

2 randomization

Participants are randomly assigned to receive either meropenem or piperacillin/tazobactam as empirical treatment.

Both medications are administered intravenously as a solution for infusion or injection.

3 treatment administration

The assigned medication is administered according to the study protocol, which involves intravenous use.

The duration and frequency of administration are determined by the study guidelines and the participant’s medical condition.

4 monitoring and follow-up

Participants are monitored for any serious adverse reactions, such as anaphylactic shock, invasive fungal infection, pseudomembranous colitis, or toxic epidermal necrolysis, within 30 days of randomization.

The study also tracks the number of participants requiring new isolation precautions due to resistant bacteria within 30 days.

5 evaluation of outcomes

Primary outcomes include all-cause mortality at day 30 after randomization.

Secondary outcomes include days alive without life support, days alive and out of hospital, and all-cause mortality at days 90 and 180.

Health-related quality of life (HRQoL) is assessed at day 180 using specific index values.

Who Can Join the Study?

Must be 18 years or older.
Must have sepsis or septic shock. This means there is a suspected or confirmed infection and a sudden increase of 2 or more points in the SOFA score, which is a way to measure how well the organs are working.
Must be critically ill, which means needing at least one of the following:
- Invasive mechanical ventilation: A machine helps with breathing through a tube.
- Non-invasive ventilation: A mask or similar device helps with breathing.
- Continuous use of CPAP: A machine provides constant air pressure to help with breathing due to low oxygen levels.
- Oxygen supplementation: Receiving oxygen at a flow of 10 liters per minute or more, regardless of how it is given.
- Continuous infusion of vasopressors or inotropes: Medications given through a drip to support blood pressure or heart function, not including those given only for procedures.
Must have a clinical need for treatment with either meropenem or piperacillin/tazobactam, which are types of antibiotics.

Who Cannot Join the Study?

Patients who are not critically ill adults. This means the study is only for adults who are very sick and need special medical care.
Patients who do not have sepsis or septic shock. Sepsis is a serious condition where the body has a strong reaction to an infection, and septic shock is a severe form of sepsis that can cause dangerously low blood pressure.
Patients who are not within the specified age range. The study is for adults, so children and teenagers cannot participate.
Patients who are not part of the specified clinical trial groups. This means the study is looking for specific types of patients based on certain medical criteria.
Patients who are not considered part of a vulnerable population. Vulnerable populations may include people who are more at risk due to their health condition or other factors.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Odense University Hospital	Odense	Denmark
Lillebaelt Hospital	Kolding	Denmark
Slagelse Hospital	Slagelse	Denmark
Aalborg University Hospital	Aalborg	Denmark
Holbaek Sygehus	Holbæk	Denmark
Region Joenkoepings Laen	Jönköping	Sweden
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Region Sjaelland	Holbæk	Denmark
Regionshospital Nordjylland	Hjørring	Denmark
Nykoebing F Sygehus	Nykobing	Denmark
Hvxryspa Hmuzfzff	Hvidovre	Denmark
Hqqrbzrr Hiylwbed	Hillerød	Denmark
Hslfmk Hlnfdhxx	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2024
Sweden	Not yet recruiting	01.03.2024

Trial locations

Investigated drugs:

Meropenem is an antibiotic used to treat severe infections caused by bacteria. In this trial, it is being tested to see how effective it is in treating critically ill adults with sepsis, a serious condition that occurs when the body’s response to an infection causes injury to its own tissues and organs.

Piperacillin/Tazobactam is a combination antibiotic that works by killing bacteria and preventing their growth. It is also being tested in this trial to determine its effectiveness in treating sepsis in critically ill adults. The goal is to compare its effects with those of Meropenem on patient outcomes, including survival rates.

Septic Shock – Septic shock is a severe and potentially life-threatening condition that occurs when an infection leads to dangerously low blood pressure and abnormalities in cellular metabolism. It is a progression from sepsis, where the body’s response to infection causes widespread inflammation. This inflammation can lead to blood clots and leaky blood vessels, impairing blood flow and oxygen delivery to organs. As a result, organs may begin to fail, and the patient may experience symptoms such as confusion, rapid heart rate, and difficulty breathing. The condition requires immediate medical attention to stabilize blood pressure and support organ function.

Sepsis – Sepsis is a serious medical condition that arises when the body’s response to an infection injures its own tissues and organs. It can lead to widespread inflammation, blood clotting, and impaired blood flow, which can cause damage to multiple organ systems. Symptoms may include fever, increased heart rate, increased breathing rate, and confusion. If not promptly treated, sepsis can progress to severe sepsis and septic shock, which are more critical stages. Early recognition and intervention are crucial to prevent further complications and support recovery.

Trial ID:

2023-509703-33-00

NCT ID:

NCT06184659

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Meropenem and Piperacillin/Tazobactam for Adults with Sepsis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?