Study of Cefazolin for Patients on Chronic Hemodialysis with Infections

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What is this study about?

This clinical trial focuses on patients undergoing chronic hemodialysis who are suffering from infections. The study is examining the use of a medication called cefazolin, which is a type of antibiotic used to treat bacterial infections. The purpose of the study is to understand how cefazolin behaves in the body of patients who are on long-term dialysis treatment.

Participants in the study will receive cefazolin as part of their regular care. The study will monitor how the medication is processed in the body, specifically looking at how long the drug stays in the bloodstream at effective levels. This will help determine the best way to use cefazolin in treating infections in these patients. The study will also observe any side effects that may occur within six weeks after the last dose of the medication.

Throughout the study, researchers will assess the early and late effectiveness of cefazolin in treating infections. Early effectiveness will be checked one week after starting treatment, while late effectiveness will be evaluated six weeks after starting treatment. The study aims to ensure that the medication is working properly and to identify any factors that might affect how the drug is processed in the body. This information will be valuable in improving treatment for patients with infections who are on chronic hemodialysis.

1 joining the study

Participation begins after signing an informed consent form. Eligibility includes being 18 years or older, undergoing chronic intermittent dialysis, and having an indication for cefazolin treatment due to infection.

2 treatment initiation

Cefazolin is administered for the treatment of infections. The medication is given through parenteral use, which means it is delivered by injection.

3 blood sample collection

Blood samples are taken either from a peripheral vein or from the dialysis machine. This occurs until the next dialysis session, which is scheduled 48 hours later.

4 monitoring plasma concentration

The primary goal is to monitor the time during which the plasma concentration of cefazolin remains above 40 mg/L.

5 monitoring for adverse events

Adverse events are monitored for up to 6 weeks after the last dose of cefazolin.

6 early clinical efficacy assessment

One week after starting treatment, the effectiveness of cefazolin is evaluated. Success is defined by the absence of fever, negative blood cultures, no infection-related death, and no change in antibiotic therapy due to ineffectiveness.

7 late clinical efficacy assessment

Six weeks after starting treatment, a further assessment of cefazolin’s effectiveness is conducted. Criteria include negative blood cultures, no recurrence of infection, no infection-related death, and no change in antibiotic therapy due to ineffectiveness.

8 pharmacokinetic variability analysis

Factors that may affect the concentration of cefazolin in the blood are analyzed. This includes checking for concentrations below 40 mg/L or above 80 mg/L.

Who Can Join the Study?

Participants must be 18 years or older.
Participants must be on chronic intermittent dialysis, which means they regularly receive a treatment to clean their blood because their kidneys are not working properly.
Participants must need cefazolin, a type of antibiotic, for one of the following reasons:
- To treat a possible infection caused by SAMS, which stands for Staphylococcus aureus Methicillin-Sensitive, a type of bacteria.
- To treat an infection in the blood caused by Gram-positive cocci, which are a group of bacteria.
Participants must be able to have blood samples taken from their arm or from the dialysis machine until their next dialysis session, which is 48 hours later.
Participants must be covered by or entitled to social security, meaning they have access to government health benefits.
Participants must have signed an informed consent form, which means they agree to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients who are not on chronic haemodialysis. This means patients who do not regularly receive a treatment that filters waste and water from the blood, like the kidneys would do.
Patients who do not have an infection. An infection is when harmful germs enter the body and cause illness.
Patients who are not part of the specified age range. The study is looking for patients within certain age groups.
Patients who are part of a vulnerable population. This refers to groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Coxlyv Hsrlqyujegx Remsnith Ueruikuflxbhn Db Tjrki	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	20.11.2023

Trial locations

Investigated drugs:

Cefazolin

Cefazolin is an antibiotic used to treat infections. In this clinical trial, the study focuses on understanding how cefazolin behaves in the body of patients who are undergoing chronic haemodialysis. The goal is to learn more about how the medication is processed and eliminated in these patients, which can help in optimizing its use as part of their routine care.

Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time, leading to the accumulation of waste products and fluid imbalances in the body. Patients with chronic kidney disease may require dialysis, a process that artificially removes waste and excess fluid from the blood. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. Infections can be a common complication due to the weakened immune system and frequent medical interventions. Managing the disease often involves lifestyle changes and regular monitoring to slow progression and manage symptoms.

Trial ID:

2023-506734-73-00

Protocol code:

DR220268

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Cefazolin for Patients on Chronic Hemodialysis with Infections

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