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Study Comparing Norfloxacin and Conventional Antibiotics for Hospitalized Patients with Decompensated Cirrhosis 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 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 research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing an informed consent form. This may be done by the patient or their legal representative or close relative.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of decompensated cirrhosis and a bacterial infection that has developed within the last 48 hours.

  3. Step 3

    Randomization

    Participants are randomly assigned to one of two groups: one receiving conventional antibiotic treatment and the other receiving treatment guided by epidemiological surveillance.

  4. Step 4

    Treatment administration

    The medication Norfloxacino Sandoz 400 mg is administered orally in tablet form. The specific dosage and frequency are determined by the assigned treatment group and the patient's condition.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for the development of antibiotic resistance, defined by new colonizations or infections by multidrug-resistant organisms (MDROs), over a period of 28 days.

    Additional evaluations include the resolution of the infection, changes in health scores, and the need for intensive care or life support.

  6. Step 6

    Outcome assessment

    The primary outcome is the probability or rate of developing antibiotic resistance within 28 days.

    Secondary outcomes include the rate of MDRO colonization and infection, infection resolution, hospital stay duration, and survival rates at 28 days.

Who can join the trial?

5 criteria

  • Patients must have **cirrhosis**, which is a condition where the liver is damaged and scarred.
  • Patients must be experiencing **acute decompensation**, meaning their liver condition has suddenly worsened.
  • Patients must be **18 years or older**.
  • Patients must have a **proven or suspected bacterial infection** that requires treatment with antibiotics.
  • Patients or their legal representatives or close relatives must provide **signed informed consent**, which means they agree to participate in the study after understanding its details.

Who cannot join the trial?

5 criteria

  • Patients who are not hospitalized with **decompensated cirrhosis**. This means the liver is severely damaged and not working properly.
  • Patients who have not been diagnosed with a **bacterial infection** that has been present for 48 hours or less.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specified clinical trial group.
  • Patients who are not part of the vulnerable population selected for the study.
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Investigated drugs

  • Conventional Antibiotic Strategies

    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.

  • Regimens Guided by Epidemiological Surveillance

    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.

What is already known about the treatment

  • Conventional Antibiotic Strategies

    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.

  • Regimens Guided by Epidemiological Surveillance

    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.

Investigated diseases

Decompensated Cirrhosis – This is a severe stage of liver cirrhosis where the liver can no longer perform its vital functions effectively. It often results in complications such as jaundice, ascites, and hepatic encephalopathy. Patients may experience symptoms like fatigue, confusion, and swelling in the abdomen or legs. The progression of the disease can lead to further liver damage and increased vulnerability to infections. In this context, patients with decompensated cirrhosis are at risk of developing bacterial infections, which can complicate their condition. The disease requires careful management to prevent further deterioration and manage symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519974-38-00Protocol codeSURVIC_STUDYEstimated enrolment198 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

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