Hospital Clinic De Barcelona
Barcelona, Spain
Rare diseases
Investigational molecules
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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on patients with cirrhosis, a condition where the liver is severely damaged and scarred. The study involves patients who are hospitalized with a sudden worsening of their cirrhosis, known as decompensated cirrhosis, and have a bacterial infection that has been present for 48 hours or less. The trial will compare two different approaches to treating these infections: a conventional antibiotic strategy and a strategy guided by monitoring the spread of bacteria in the hospital environment.
The treatment being studied includes the use of Norfloxacin, an antibiotic that comes in tablet form. The purpose of the study is to evaluate how likely it is for patients to develop resistance to antibiotics within 28 days of starting treatment. This will be assessed by looking for new bacterial infections or colonizations that are resistant to multiple drugs, known as MDROs (multi-drug resistant organisms).
Participants in the study will receive either the conventional antibiotic treatment or the new strategy based on hospital bacteria monitoring. The study will track various outcomes, such as the development of antibiotic resistance, the resolution of infections, and the overall health and survival of the patients during their hospital stay and up to 28 days after treatment begins. The trial aims to provide insights into the best ways to manage bacterial infections in patients with decompensated cirrhosis, potentially improving treatment strategies and patient outcomes.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
5 criteria
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Barcelona, Spain
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are standard treatments used to fight infections. These antibiotics are chosen based on common practices and guidelines for treating infections in patients with cirrhosis. The goal is to eliminate the infection and prevent it from spreading.
involve using antibiotics selected based on specific data about the types of bacteria present in the environment or community. This approach aims to target the bacteria more precisely, potentially reducing the risk of antibiotic resistance by using the most effective treatment for the specific bacteria causing the infection.
These antibiotics are typically administered orally or intravenously, depending on the specific medication and patient needs. They are widely used in medical practice and literature for treating bacterial infections, including those in patients with cirrhosis. The main therapeutic indication is to combat bacterial infections in hospitalized patients with decompensated cirrhosis. At the molecular level, these antibiotics work by targeting and inhibiting essential bacterial processes, such as cell wall synthesis or protein production, leading to the death or inhibition of bacterial growth. They are classified pharmacologically as antibacterial agents.
These regimens involve the administration of antibiotics based on current epidemiological data, often given orally or intravenously. This approach is gaining attention in medical literature as a strategy to optimize antibiotic use and reduce resistance. The primary therapeutic indication is to treat bacterial infections in patients with cirrhosis, with a focus on minimizing the development of antibiotic resistance. The mechanism of action depends on the specific antibiotics used, which may include inhibiting bacterial cell wall synthesis or protein production. These regimens are classified as targeted antibacterial therapies.
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