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Randomized controlled study comparing conventional antibiotic regimens versus antimicrobial strategies guided by epidemiological surveillance in patients infected with cirrhosis.
EU CTIS ID: 2024-519974-38-00
What this study is testing
To evaluate the probability/rate of antibiotic resistance development at 28 days after inclusion in both groups of patients, defined based on the appearance of new colonizations and/or infections by MDROs.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cirrhotic patients with acute decompensation aged ≥18 years.
- Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).
- Signed informed consent or consent given by their legal representatives or close relatives.
You likely can't join if
- Bacterial infection lasting for > 48 hours.
- Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical prac- tice.
- MDR colonization or infection in the last month.
- Evidence of current locally advanced or metastatic malignancy (pa- tients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).
- Pregnant and/or breast-feeding woman.
- Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision-maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.