NORFLOXACIN for Decompensated cirrhosis | Bacterial infection

Inclusion criteria

• {"criterion_text":"- Cirrhotic patients with acute decompensation aged ≥18 years.\n- Proven or suspected bacterial infection requiring antibiotic therapy (diagnosis will be established according to local guidelines, Appendix 1).\n- Signed informed consent or consent given by their legal representatives or close relatives."}

Exclusion criteria

• {"criterion_text":"- Bacterial infection lasting for > 48 hours.\n- Infection in a critically ill cirrhotic patient (ICU admission). In this population, epidemiological surveillance is standard clinical practice.\n- MDR colonization or infection in the last month.\n- Evidence of current locally advanced or metastatic malignancy (patients with hepatocellular carcinoma within the Milan criteria and non-melanocytic skin cancer can be included).\n- Pregnant and/or breast-feeding woman.\n- 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."}

Primary endpoints

• {"endpoint_text":"- Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days (composite variable: MDRO colonization and/or infection).","definition_or_measurement_approach":"Measured at 28 days after inclusion as a composite variable defined by the appearance of new colonizations and/or infections by MDROs."}

Secondary endpoints

• {"endpoint_text":"- Evaluate the impact of both antibiotic strategies on: - Rate and probability of developing antibiotic resistance during hospitalization. - Rate and probability of MDRO colonization during hospitalization and at 28 days. - Rate and probability of MDRO infection during hospitalization and at 28 days. - Infection resolution rate with initial and final strategies. - Evolution of scores: ACLF, MELD, Child-Pugh, CLIF-OF, CLIF- C AD, and CLIF-C ACLF score.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Days of admission to the ICU if needed.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Days of hospital stay.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of rehospitalizations.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Antibiotics consumption (days, dose and type of antibiotics) and health costs (cost of antibiotic, cost of hospital/ICU stay and of organ support(s)).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Hospital and 28-day survival.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

11-12-2024

Latest Decision Or Authorization Date

19-12-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

198

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain