Study Comparing Different Antibiotic Treatments for ICU Patients with Hospital-Acquired Sepsis: Focus on Cefepime and Drug Combination

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What is this study about?

This clinical trial is focused on studying the treatment of sepsis, a serious condition that occurs when the body has an extreme response to an infection. The study will explore different ways of administering antibiotics to patients with sepsis acquired in the hospital. The antibiotics being studied include Avibactam, Ceftazidime, Tazobactam, Ceftolozane, Piperacillin, Cefepime, Amikacin, Meropenem, and Linezolid. Some of these medications are used in combination, such as Ceftazidime and Avibactam or Piperacillin and Tazobactam, to enhance their effectiveness against infections.

The purpose of the study is to compare the effectiveness of two different methods of administering these antibiotics: intermittent infusion and continuous infusion. This means that the study will look at whether giving the antibiotics in separate doses at intervals or continuously over time is more effective in reducing the 30-day mortality rate of patients with sepsis in the intensive care unit (ICU). The study will also involve a comparison with a placebo group to better understand the impact of the antibiotics.

Participants in the study will receive one of the antibiotic treatments for a period of up to seven days. The study will monitor the patients’ health and recovery over a 30-day period to assess the outcomes. The goal is to determine which method of antibiotic delivery is more beneficial for patients with sepsis, potentially leading to improved treatment strategies in the future.

1 joining the study

Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes verifying the diagnosis of hospital-acquired sepsis and ensuring the presence of specific risk factors for resistant bacteria.

2 treatment initiation

Treatment involves the administration of antibiotics. The specific antibiotics used include avibactam, ceftazidime, tazobactam, ceftolozane, piperacillin, cefepime, amikacin, and meropenem. These are administered through injection or infusion, depending on the specific medication and treatment plan.

3 treatment administration

The antibiotics are given either intermittently or continuously, depending on the assigned group. The mode of administration is a key aspect of the study, comparing the effects of different delivery methods on patient outcomes.

4 monitoring and assessment

Throughout the treatment, regular monitoring is conducted to assess the effectiveness of the antibiotics and to check for any side effects. This includes measuring drug concentrations and evaluating the patient’s response to treatment.

5 evaluation of outcomes

The primary outcome measured is the mortality rate at 30 days. Secondary outcomes include clinical failure, infection rates, and organ function. These outcomes help determine the effectiveness of the treatment methods.

6 completion of study participation

Participation in the study concludes after the final assessments are completed. This includes a review of the patient’s health status and any long-term effects of the treatment.

Who Can Join the Study?

Must be an adult (18 years or older).
Must have hospital-acquired sepsis, which means the infection was acquired in the hospital. This is defined as being hospitalized for more than 48 hours or discharged less than 48 hours ago, and sepsis diagnosed within the last 24 hours.
Must have one of the following risk factors for certain types of bacteria that are hard to treat with antibiotics:
- Used intravenous antibiotics within 7 days before sepsis started, except for certain antibiotics that only work against specific bacteria.
- Stayed in the hospital for 15 days or more within 3 months before sepsis started.
- Used a breathing machine for 5 days or more within 3 months before sepsis started.
- Have medical devices like dialysis lines, catheters, or feeding tubes.
- Known to have or carry certain hard-to-treat bacteria within 3 months before sepsis started.
- Used specific antibiotics like amoxicillin-clavulanic acid, C2G, C3G, or fluoroquinolones within 3 months before sepsis started.
- Traveled to areas with a higher risk of these bacteria, such as the Indian subcontinent, South-East Asia, the Middle East, North Africa, or the Mediterranean Basin, within 3 months before sepsis started.
- Have a problem with the urinary tract if the infection is in the urinary tract.
Must have had appropriate tests done to identify the bacteria before starting treatment.
Must be expected to stay in the Intensive Care Unit (ICU) for more than 3 days.

Who Cannot Join the Study?

Patients who are not in the Intensive Care Unit (ICU) with hospital-acquired sepsis cannot participate.
Patients who are not receiving antibiotic treatment for sepsis are excluded.
Patients who are not within the specified age range for the study cannot join. The study includes certain age groups only.
Patients who belong to a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Jean Perrin	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Pellegrin Hospital	Bordeaux	France
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Hospitalier De Saint-Denis	St Denis	France
Centre Hospital Region Metz Thionville	Metz	France
Iijnefkw Muyjcqwpth Mbrpqnhsfc	Paris	France
Czjmqm Hwmpovqdxrm Sse Egdwmhssmitfguxnbblrjmt	Etampes	France
Cbt Chcot Rdutnwughdy	Lyon	France
Hzaesrnd Uynlzvcuftuxmb Saflbpchut &ssffnj Hwvjske dr Hihwoeizyjc	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	04.12.2024

Trial locations

Investigated drugs:

Beta-lactam Antibiotic is a type of antibiotic used to treat bacterial infections. In this trial, it is being studied to see if different ways of giving the medication can affect the survival of patients with sepsis in the ICU. The study is comparing intermittent infusion (giving the medication at intervals) versus continuous infusion (giving the medication continuously) to see which method is more effective in reducing mortality.

Combination Antibiotic Therapy involves using more than one antibiotic at the same time to treat infections. This approach is being tested in the trial to determine if using a combination of antibiotics can improve outcomes for patients with sepsis compared to using a single antibiotic. The goal is to find the best treatment strategy to help patients recover from severe infections.

Investigated diseases:

Sepsis

Sepsis – Sepsis is a severe and potentially life-threatening condition that arises when the body’s response to infection causes injury to its own tissues and organs. It typically begins with an infection that can be located anywhere in the body, such as the lungs, urinary tract, skin, or gastrointestinal tract. As the infection progresses, the immune system releases chemicals into the bloodstream to fight the infection, which can trigger widespread inflammation. This inflammation can lead to a cascade of changes that damage multiple organ systems, causing them to fail. The progression of sepsis can be rapid, and it requires prompt medical attention to prevent further complications.

Trial ID:

2024-516849-39-01

Protocol code:

APHP180596

NCT ID:

NCT05681442

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Different Antibiotic Treatments for ICU Patients with Hospital-Acquired Sepsis: Focus on Cefepime and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?