Study of antibiotic treatment effectiveness in critically ill patients receiving drug combination therapy

3 1 1 1

What is this study about?

This clinical trial aims to study antibiotic levels in critically ill patients receiving intravenous antibiotic treatment for serious infections. The study will measure how well different antibiotics like vancomycin, meropenem, piperacillin, ceftazidime, and other commonly used antibiotics reach effective concentrations in the blood of patients in intensive care units.

The research will analyze blood samples from patients who are receiving antibiotics as part of their normal treatment in the intensive care unit. The main goal is to determine if current antibiotic dosing practices achieve the right levels of medication in the blood to effectively treat infections in critically ill patients.

The study will track antibiotic concentrations in the blood and monitor treatment outcomes, including how well the infection responds to treatment and any side effects that may occur. This information will help improve understanding of how antibiotics work in critically ill patients and may lead to better dosing recommendations for future treatment.

1 Initial qualification

You must be admitted to an Intensive Care Unit (ICU) to participate in the study

You need to be receiving one of the specified intravenous antibiotics for treating an infection

You must have been taking the study antibiotic for at least 24 hours

Your age must be at least 1 month (corrected gestational age)

2 Medical requirements

You must have suitable intravenous or intra-arterial access for blood sample collection

The medical team will monitor your antibiotic levels in blood samples

The study will track how the antibiotics work in your body through blood measurements

3 Monitoring period

Your antibiotic levels will be measured throughout the treatment

The medical team will monitor your condition for up to 30 days after starting the antibiotic

They will check if the treatment is successful and record any side effects

Additional monitoring will continue for 14 days to check for resistant organisms

4 Study completion

The medical team will record how many days you spent outside the ICU within the 30-day period

They will document your health status at day 14 and day 30 after starting the antibiotic

The study will track any adverse events related to the antibiotic treatment

Who Can Join the Study?

You must be a patient in the Intensive Care Unit (ICU)
You must be currently receiving intravenous antibiotics (medicine given through a vein) to treat an infection
You must have a suitable intravenous or intra-arterial line (a tube inserted into your vein or artery) that allows for blood sample collection
You must be at least 1 month old (adjusted for premature birth if applicable)
You must have been receiving the study antibiotic for at least 24 hours
You must be able to provide informed consent (written permission to participate in the study) or have someone legally authorized to provide consent on your behalf
Both male and female patients can participate
Adults and children can participate in the study

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnant or breastfeeding women
Known allergic reactions to any of the study antibiotics
Severe kidney disease requiring dialysis (a treatment that filters waste from blood when kidneys don’t work properly)
Severe liver disease (where the liver is not functioning properly)
Patients receiving palliative care (care focused on comfort rather than cure)
Inability to provide informed consent
Participation in another clinical trial within the past 30 days
Patients with compromised immune system (weakened ability to fight infections)
History of severe adverse reactions to antibiotics
Patients with conditions that might interfere with antibiotic absorption
Terminal illness with life expectancy less than 3 months
Active cancer treatment that might affect antibiotic effectiveness
Severe burns affecting more than 20% of body surface
Patients requiring specialized medication that could interact with study antibiotics

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Cazt Df Nfoti	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.12.2025

Trial locations

Investigated drugs:

Antibiotics are medications used to treat bacterial infections. In this study, researchers are examining how these medications work in critically ill patients who are in intensive care units. The study aims to measure the levels of antibiotics in patients’ bodies to ensure they are receiving the right amount of medication to effectively treat their infections. This is important because critically ill patients may process medications differently than other patients, which could affect how well the antibiotics work.

Since the specific antibiotics are not listed in the source data, I cannot provide details about individual medications. The study appears to be focused on measuring antibiotic concentrations in general, rather than testing specific antibiotic products.

Serious Bacterial Infection in Critical Care – A condition where harmful bacteria invade the body of critically ill patients, causing severe infection that affects vital organs and body systems. The infection develops rapidly and can occur in various parts of the body, including the bloodstream, lungs, or other organs. These infections often emerge when patients are already weakened by other medical conditions or procedures. The body’s immune response to the infection can lead to widespread inflammation. Patients typically experience symptoms such as fever, altered vital signs, and organ dysfunction.

Methicillin-Resistant Staphylococcus Aureus (MRSA) – A type of bacteria that has developed resistance to many common antibiotics. MRSA can cause infections in different parts of the body, from skin infections to more serious internal infections. The bacteria can spread through direct contact with an infected wound or by sharing personal items that have touched infected skin. MRSA infections often begin as swollen, painful red bumps that may resemble pimples or spider bites. The affected area might be warm to touch and full of pus or other drainage.

Trial ID:

2024-516232-10-00

Protocol code:

LOCAL/2024/CR-03

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of antibiotic treatment effectiveness in critically ill patients receiving drug combination therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?