AuthorisedTherapeutic use (Phase IV)Interventional

TIME-TO-LIA : Optimal Duration of Antibiotic Therapy in Drained Pyogenic Liver Abscess: 3 weeks versus 6 weeks, a non-inferiority trial

This study is investigating the optimal duration of antibiotic therapy for pyogenic liver abscesses, which are pockets of pus in the liver. It's comparing two treatment lengths: 3 weeks versus 6 weeks, after the abscess has been drained. The main goal is to see if treating for 3 weeks is just as good, or 'non-inferior,' to treating for 6 weeks, in preventing the problem from coming back or new issues arising within 12 weeks of finishing treatment. This research is important because it could help doctors understand if a shorter course of antibiotics is just as effective, potentially leading to fewer side effects and less antibiotic resistance. Participants will be adults diagnosed with a liver abscess who have had it drained.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

456

Start

06 Oct 2025

Pyogenic liver abscess

What is this study about?

Imagine your liver, an important organ that cleans your blood and helps digest food, gets an infection that forms a pocket of pus, like a localised boil. This is called a pyogenic liver abscess. Doctors usually treat this by draining the pus and giving antibiotics to kill the remaining bacteria. But how long should you take those antibiotics for? That's exactly what this study, called TIME-TO-LIA, aims to find out.

Currently, there isn't one clear answer for the best length of antibiotic treatment after the abscess has been drained. Some doctors might prescribe antibiotics for 3 weeks, while others might go for 6 weeks or even longer. This study is designed to compare these two common approaches – 3 weeks versus 6 weeks of antibiotics – to see if the shorter 3-week course is just as good as the longer 6-week course. By 'just as good,' we mean whether it prevents the infection from coming back or causing other problems within 12 weeks after you stop taking the medicine.

This research is really important because if a shorter course of antibiotics (3 weeks) is proven to be just as effective and safe, it could offer several benefits. Patients might experience fewer side effects from the medication, and there could be a reduced risk of bacteria becoming resistant to antibiotics, which is a growing concern. The study is particularly interested in adults who have had their liver abscess drained and are beginning antibiotic treatment. It's considered a 'Phase IV' study, which means it's looking at the best ways to use treatments that are already approved and in general use.

Key takeaways

The study compares 3 weeks vs. 6 weeks of antibiotics for liver abscesses.
It aims to find the best duration of treatment after the abscess has been drained.
Participation involves taking prescribed antibiotics and regular check-ups.
The goal is to see if a shorter course is just as safe and effective.
This research could help reduce antibiotic side effects and resistance in the future.

Who may be eligible?

To take part in this study, you need to be an adult, at least 18 years old. Both men and women are welcome to participate. Most importantly, you must have been diagnosed with a pyogenic liver abscess, which is a collection of pus in your liver, and this abscess must have been drained by doctors.

If you meet these main criteria, your doctors will also check other details about your health to make sure that taking part in this specific study is safe and appropriate for you. They will review your medical history to ensure there are no specific conditions that would prevent you from joining. This careful checking process helps keep you safe and ensures the study results are reliable.

Ultimately, the decision to participate will be made after discussions between you and the study doctors, who will explain everything in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a pyogenic liver abscess?
Has your liver abscess already been drained by doctors?
Are you able to agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your journey will involve a few key steps. After your liver abscess has been drained, you'll be randomly assigned to either receive antibiotics for 3 weeks or for 6 weeks. This decision is made by chance, like flipping a coin, to ensure a fair comparison.

You'll be taking antibiotics which may include common ones like MEROPENEM, LINEZOLID, or METRONIDAZOLE, among others, as prescribed by your doctor. The study will carefully monitor how well you respond to treatment and track if the infection clears up. You'll likely have doctors' appointments and scans to check on your liver abscess at different points, such as at 3 weeks, 6 weeks, and 12 weeks after the drainage.

During these visits, the study team will be looking at various things including your overall health, any side effects you might experience, and whether the abscess is completely gone on imaging tests. They might also take samples, like a rectal swab, to check for certain bacteria. The main follow-up period for measuring the study's success is up to 12 weeks after your treatment ends, but they will also look at any important medical events that might happen up to 6 months after drainage. The total duration of your active involvement with doctors' visits for the study's main assessments will be a few months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you would be under close medical supervision, and your treatment for a liver abscess would be carefully monitored. The study also aims to help future patients by finding the most effective and safest duration of antibiotic treatment. However, there's always a possibility that the assigned treatment duration might not be ideal for you, or you might experience side effects from the antibiotics, which can range from mild to more serious. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a pyogenic liver abscess?

It's a pocket of pus that forms in your liver, usually due to a bacterial infection. It needs to be drained and treated with antibiotics.

Why is this study comparing 3 weeks vs. 6 weeks of antibiotics?

Doctors want to find out if taking antibiotics for a shorter period (3 weeks) is just as effective and safe as a longer period (6 weeks) for liver abscesses, to improve future patient care.

What kind of antibiotics will I be taking?

The study uses antibiotics that are already approved and commonly used, like Meropenem, Linezolid, or Metronidazole, among others. Your doctor will decide what's best for you.

What does 'non-inferiority' mean in this study?

It means the study is trying to prove that the 3-week antibiotic course isn't worse than the 6-week course, hoping it will be equally good or better.

Will I know which treatment group I'm in?

You will be told whether you are in the 3-week or 6-week antibiotic group. The decision about which group you are in will be made randomly.