Recruiting

Study on Adjusted Ciprofloxacin Dosing for Patients with Kidney Impairment and Bacterial Infections

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of bacterial infections using a medication called ciprofloxacin. Ciprofloxacin is an antibiotic that helps fight bacterial infections in the body. The study is particularly interested in how this medication works in patients who have impaired renal function, which means their kidneys are not working as well as they should.

The purpose of the study is to compare the effects of different doses of ciprofloxacin in patients with impaired kidney function to those with normal kidney function. Patients with impaired kidney function will receive a revised, lower dose of ciprofloxacin, either 750 mg taken by mouth once a day or 600 mg given through an intravenous (IV) line once a day. Patients with normal kidney function will receive the regular dose, which is 500 mg taken by mouth twice a day or 400 mg given through an IV line twice a day. The study will look at how much of the drug is present in the body during the first 24 hours of treatment to see if the exposure to the drug is similar between the two groups.

Participants in the study will be monitored to ensure their safety and to gather information on how the drug is processed in their bodies. The study aims to provide valuable insights into the appropriate dosing of ciprofloxacin for patients with different levels of kidney function, which could help improve treatment outcomes for those with bacterial infections.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing informed consent and meeting the inclusion criteria, which include being treated with ciprofloxacin either intravenously or orally as part of standard care and being at least 18 years old.
Step 2
Treatment administration
The study involves the administration of ciprofloxacin to treat bacterial infections. The medication is given either orally or intravenously.
For patients with impaired kidney function, the dosage is adjusted to 750 mg orally once daily or 600 mg intravenously once daily.
For patients with normal kidney function, the standard dosage is 500 mg orally twice daily or 400 mg intravenously twice daily.
Step 3
Monitoring drug exposure
The primary focus is to monitor drug exposure during the first 24 hours of treatment. This is measured to ensure that the drug levels are similar between patients with different kidney functions.
Step 4
Completion of study participation
The study is expected to conclude by December 31, 2026. Participation continues until the study's objectives are met or until the participant's treatment course is completed.

Who can join the trial?

4 criteria

Must be receiving treatment with **ciprofloxacin**, which is an antibiotic, either through an **intravenous (iv)** method, meaning directly into a vein, or **orally (po)**, meaning by mouth, as part of standard care.
Must be at least 18 years old.
Must be admitted to the general wards of specific hospitals: Amsterdam UMC – location AMC, OLVG- location Oost, or Noordwest Ziekenhuisgroep.
Must have given **informed consent**, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

4 criteria

Patients with a **bacterial infection** cannot participate. A bacterial infection is when harmful bacteria enter the body and cause illness.
Patients with **impaired renal function** are excluded. This means their kidneys are not working well, specifically if their eGFR (a test that measures kidney function) is less than 30 ml/min/1.73m².
Patients who are not within the specified **age range** cannot participate. The age range for this study is not specified here, but it is important for eligibility.
Patients who are part of a **vulnerable population** are not allowed to join. This refers to groups of people who might need special protection or care.

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Ciprofloxacin is an antibiotic used to treat various bacterial infections. In this clinical trial, the study aims to compare the effects of different dosing regimens of ciprofloxacin in patients with impaired renal function versus those with normal renal function. The goal is to determine if the drug exposure is similar between the two groups, ensuring that patients with kidney issues receive an effective and safe dose.

What is already known about the treatment

Ciprofloxacin – Ciprofloxacin is an antibiotic administered either orally or intravenously, used primarily to treat bacterial infections. It is currently well-established in medical practice and literature as an effective treatment for a variety of bacterial infections. The main therapeutic indication for ciprofloxacin is the treatment of bacterial infections, particularly in patients with impaired renal function. At the molecular level, ciprofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication and cell division. It is classified pharmacologically as a fluoroquinolone antibiotic.

Investigated diseases

Bacterial Infection – Bacterial infections occur when harmful bacteria enter the body and begin to multiply, potentially causing illness. These infections can affect various parts of the body, including the skin, lungs, and urinary tract. Symptoms often include fever, fatigue, and localized pain or swelling, depending on the infection site. The progression of a bacterial infection can vary widely; some may resolve on their own, while others can spread and lead to more severe health issues if not addressed. The body's immune system typically responds to fight off the bacteria, but in some cases, medical intervention may be necessary to assist in recovery.