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Study comparing 3-week versus 6-week antibiotic treatment for patients with drained pyogenic liver abscess

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on treating pyogenic liver abscess, which is a collection of pus in the liver caused by bacterial infection. The study aims to determine if 3 weeks of antibiotic treatment is as effective as 6 weeks of treatment after drainage of the abscess. Various antibiotics will be used including meropenem, linezolid, tedizolid, sulfamethoxazole with trimethoprim, ceftazidime with avibactam, daptomycin, colistin, metronidazole, amikacin, and imipenem with cilastatin.

The medications will be given either by mouth or through a vein, depending on the specific antibiotic used. The treatment begins after the abscess has been drained through a medical procedure. Patients will be monitored for 12 weeks after the drainage procedure to assess how well the treatment worked.

The study will track several aspects of patient recovery, including how quickly the abscess disappears on imaging tests, how long patients stay in the hospital, and whether there are any complications or side effects from the treatment. Doctors will also monitor for any return of the infection and check how the antibiotics affect bacteria in the digestive system.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    A CT scan will be performed to confirm the presence of liver abscess

    A sample of fluid from the liver abscess will be taken to identify the bacteria causing the infection

    Your eligibility for participation requires you to be at least 18 years old

  2. Step 2

    Drainage procedure

    The liver abscess will be drained through a thin tube placed through the skin (percutaneous drainage) or by needle aspiration

    A follow-up scan will be performed 10 days (plus/minus 2 days) after drainage to confirm that the abscess size has decreased by more than 50%

  3. Step 3

    Antibiotic treatment

    You will receive antibiotic treatment through one of two possible durations:

    Option 1: 3 weeks of antibiotics after drainage

    Option 2: 6 weeks of antibiotics after drainage

    Antibiotics may be given through a vein (intravenous) or by mouth (oral), including medications such as meropenem, linezolid, daptomycin, or other appropriate antibiotics

  4. Step 4

    Follow-up assessments

    Your liver abscess will be checked by imaging at weeks 3, 6, and 12 after drainage

    A bacterial test using a rectal swab will be performed at the start and at week 12

    Your progress will be monitored for any complications or side effects

    A final assessment will occur at week 12 to determine if the treatment was successful

  5. Step 5

    Extended monitoring

    Additional follow-up will continue until 6 months after treatment

    Any new health issues or recurrence of infection will be documented

    The study will monitor for any adverse effects from the treatment

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have a liver abscess (a collection of pus in the liver) confirmed by a CT scan (special X-ray imaging)
  • Must have bacteria found in the pus sample taken from the liver abscess through laboratory testing
  • Must show successful drainage of the abscess, meaning the size of the abscess has decreased by more than 50% when checked by ultrasound or CT scan about 10 days after the drainage procedure
  • Can be either male or female
  • The drainage can be done either through:
    • Percutaneous drainage (inserting a thin tube through the skin to drain the abscess)
    • Aspiration (removing fluid using a needle)

Who cannot join the trial?

13 criteria

  • Age under 18 years old
  • Presence of septic shock (a serious condition where blood pressure drops dangerously low due to infection)
  • Immunocompromised patients (people with weakened immune systems)
  • Patients who cannot receive oral antibiotics
  • Known allergy to the study medications
  • Pregnant or breastfeeding women
  • Patients with multiple liver abscesses (more than one infected area in the liver)
  • Patients who have already started antibiotic treatment for more than 48 hours
  • Patients unable to provide informed consent
  • Patients with severe liver disease
  • Patients with polymicrobial infection (infection caused by multiple types of bacteria)
  • Patients who cannot attend follow-up visits
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

Antibiotic therapy This trial evaluates antibiotic treatment used after draining liver abscesses (infected fluid collections in the liver). The antibiotics are used to clear the remaining infection after the drainage procedure. The specific antibiotics may vary depending on the type of bacteria causing the infection, but they are all medications designed to fight bacterial infections. The study compares different durations of the same antibiotic treatment to determine the most effective length of therapy.

What is already known about the treatment

  • Meropenem and vaborbactam

    This medication is administered through an intravenous injection to treat serious bacterial infections. It is a widely recognized combination used in hospital settings to combat resistant bacteria. The drug works by blocking the enzymes that bacteria need to build their protective cell walls, effectively causing them to burst. It belongs to a class of drugs known as carbapenems combined with a beta-lactamase inhibitor.

  • Linezolid

    This antibiotic is taken orally to treat various types of bacterial infections, including skin and lung infections. It is an established medicine used to target bacteria that have become resistant to other common treatments. At a molecular level, it works by preventing the bacteria from producing the proteins they need to grow and multiply. It is classified as an oxazolidinone antibiotic.

  • Tedizolid

    This medication is administered as an oral tablet to treat skin infections caused by specific bacteria. It is a newer antibiotic available for clinical use in outpatient settings. The drug functions by interfering with the bacteria's ability to make essential proteins, which stops their growth. It belongs to the oxazolidinone class of antibacterial agents.

  • Sulfamethoxazole and trimethoprim

    This combination is taken orally to treat a variety of bacterial infections. It is a well-known and frequently used treatment in medical practice. The two components work together to block two different steps in the bacteria's ability to create folic acid, which is vital for their survival. This medication is classified as a sulfonamide antibiotic combination.

  • Ceftazidime and avibactam

    This medication is given via intravenous infusion to treat complicated infections caused by highly resistant bacteria. It is an important tool in modern medicine for managing multidrug-resistant organisms. The ceftazidime component attacks the bacterial cell wall, while the avibactam protects the antibiotic from being destroyed by the bacteria's defense mechanisms. It is classified as a cephalosporin combined with a beta-lactamase inhibitor.

  • Daptomycin

    This antibiotic is administered through an intravenous injection to treat serious bloodstream infections and skin infections. It is a standard treatment for specific types of resistant bacteria in clinical settings. The drug works by attaching to the bacterial cell membrane and creating holes, which disrupts the cell's internal balance and leads to death. It is categorized as a cyclic lipopeptide antibiotic.

Investigated diseases

Pyogenic Liver Abscess - A serious infection in the liver where pus-filled cavities develop within the liver tissue. The condition occurs when bacteria enter the liver and cause an infection, leading to the formation of one or more abscesses. The infection typically begins with inflammation of liver tissue, which then progresses to the formation of pus-filled pockets. The abscess can vary in size and may be single or multiple. The condition can develop from various sources, including infections in the abdomen, blood-borne infections, or as a complication of other medical procedures.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520940-14-00Estimated enrolment456 patientsSponsorAssistance Publique Hopitaux De Paris

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