Study of Piperacillin/Tazobactam and Levofloxacin for Patients with COPD or Cystic Fibrosis

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What is this study about?

This clinical trial is focused on studying two diseases: Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF). The study will explore the effects of two medications, Levofloxacin and Piperacillin/Tazobactam, which are both given as a solution for infusion, meaning they are administered directly into the bloodstream through a vein. The purpose of the study is to compare different methods of measuring how these antibiotics behave in the lungs of patients with COPD or CF.

Participants in the study will receive either Levofloxacin or Piperacillin/Tazobactam as part of their treatment. The study will involve taking samples from the lungs to measure the concentration of the antibiotics. This will be done using three methods: collecting fluid from the lining of the lungs, taking a small tissue sample, and using a technique called in-vivo microdialysis, which involves measuring the drug concentration in the body over a period of time. These methods will help researchers understand how the drugs are distributed in the lungs.

The study will be conducted over a short period, with the main focus on comparing the three methods of measurement. The results will provide valuable information on how these antibiotics work in the lungs of patients with Chronic Obstructive Pulmonary Disease and Cystic Fibrosis, potentially leading to better treatment strategies in the future.

1 joining the study

Upon joining the study, ensure that written informed consent is provided. This confirms understanding and agreement to participate in the study.

Participation requires a planned bilateral lung transplantation and a diagnosis of either chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF).

Eligibility is limited to individuals aged over 18 and under 90 years.

2 medication administration

Receive the first medication, levofloxacin, administered as a solution for infusion. This means the medication is given directly into a vein through an intravenous (IV) line.

The second medication, piperacillin/tazobactam, is also administered as a solution for infusion through an IV line.

The specific dosage, frequency, and duration of administration will be provided by the medical team overseeing the study.

3 measurement of antibiotic levels

The study involves measuring the levels of antibiotics in the lungs using three different methods.

At 75 minutes after administration, concentrations in the epithelial lining fluid and tissue biopsy will be measured.

In-vivo microdialysis, a technique to measure drug levels in the body, will be conducted during the 60 to 90-minute interval.

4 completion of study participation

Participation in the study is expected to continue until the estimated end date of December 31, 2025.

Upon completion, all data collected will contribute to understanding the effectiveness of the medications in treating lung conditions associated with COPD and CF.

Who Can Join the Study?

Provide written informed consent. This means you agree to participate in the study after being informed about all aspects of it.
Have a planned bilateral lung transplantation. This means you are scheduled to receive a lung transplant for both lungs.
Have a diagnosis of COPD (chronic obstructive pulmonary disease) or CF (cystic fibrosis).
Be between the ages of 18 and 90 years.

Who Cannot Join the Study?

Patients with chronic obstructive pulmonary disease cannot participate. This is a long-term lung disease that makes it hard to breathe.
Patients with cystic fibrosis cannot participate. This is a genetic disorder that affects the lungs and digestive system.

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	21.10.2024

Trial locations

Investigated drugs:

Piperacillin/Tazobactam is a combination of two medications used to treat bacterial infections. Piperacillin is an antibiotic that helps kill bacteria, while Tazobactam is a substance that prevents bacteria from breaking down the antibiotic, making it more effective. In this trial, the medication is being studied to understand how it moves and is absorbed in the lungs of patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis.

Levofloxacin is an antibiotic used to treat a variety of bacterial infections. It works by stopping the growth of bacteria. In this clinical trial, researchers are examining how Levofloxacin is distributed and absorbed in the lungs of patients with COPD or cystic fibrosis. This study aims to compare different methods of measuring how the drug behaves in the body.

Investigated diseases:

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung condition that obstructs airflow from the lungs. It is characterized by breathing difficulties, cough, mucus production, and wheezing. The disease progresses slowly, with symptoms worsening over time. In COPD, the airways and air sacs lose their elastic quality, and the walls between many of the air sacs are destroyed. The walls of the airways become thick and inflamed, and the airways produce more mucus than usual, which can clog them. This leads to reduced airflow and difficulty in breathing.

Cystic Fibrosis – Cystic Fibrosis is a genetic disorder that affects the respiratory and digestive systems. It is characterized by the production of thick, sticky mucus that can clog the airways and lead to severe respiratory and digestive problems. The disease progresses as the thick mucus builds up, causing blockages and infections in the lungs and other organs. Over time, this can lead to lung damage and respiratory failure. In the digestive system, the mucus can block the ducts of the pancreas, preventing digestive enzymes from reaching the intestines. This results in difficulty absorbing nutrients and poor growth.

Trial ID:

2024-518337-29-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Piperacillin/Tazobactam and Levofloxacin for Patients with COPD or Cystic Fibrosis

What is this study about?

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