NCT05783661 Trial Comparing Conventional Antibiotic Strategies Versus Regimens Guided by Epidemiological Surveillance in Infected Patients With Cirrhosis (SURVIC_STUDY)
| NCT ID | NCT05783661 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Eva Bonfill |
| Condition | Decompensated Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2026-08 |
Trial Parameters
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Brief Summary
Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
Eligibility Criteria
Inclusion Criteria: 1. Cirrhotic patients with acute decompensation aged ≥18 years. 2. Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1). 3. Signed informed consent or consent given by their legal representatives or close relatives. Exclusion Criteria: 1. Bacterial infection lasting for \> 48 hours. 2. Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice. 3. Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included). 4. Pregnant and/or breast-feeding woman. 5. 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