Study to comparing conventrional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
Treatment according to the local guidelines of the Hospital Clinic de Barcelona.
Treatment according to the local guidelines of the Hospital Clinic de Barcelona guided by colonization/epidemiological surveillance.
Eva Bonfill
Barcelona, Spain
RECRUITINGProbability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days.
Measured by the appearance of new colonizations and/or infections by MDROs.
Time frame: 28 days
Probability of antibiotic resistance development during hospitalization in both treatment arms.
Measured by the appearance of new colonizations and/or infections by MDROs.
Time frame: During hospitalization (until discharge), assessed up to day 28.
Rate of antibiotic resistance development during hospitalization in both treatment arms.
Measured by the appearance of new colonizations and/or infections by MDROs.
Time frame: During hospitalization (until discharge), assessed up to day 28.
Rate of MDRO colonization during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new colonications by MDROs.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Probability of MDRO colonization during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new colonications by MDROs.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Rate of MDRO infection during hospitalization and at 28 days in both treatment arms.
Measured by the appearance of new infections by MDROs.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Probability of MDRO infection during hospitalization and at 28 days in both treatment arms.
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Measured by the appearance of new infections by MDROs.
Time frame: During hospitalization (until discharge), assessed up to day 28 and at 28 days.
Infection resolution rate with initial and final strategies in both treatment arms.
Measured by the number of infections resolution with initial strategies or final strategies.
Time frame: Through study completion, an average of 28 days
Evolution of score ACLF (Acute-on-Chronic Liver Failure) in both treatment arms.
Measured by the result of ACLF score. Minimum ACLF score: 6 points. Maximum ACLF score: 18 points. Higher scores means a worse result.
Time frame: Through study completion, an average of 28 days
Evolution of score MELD (Model For End-Stage Liver Disease) in both treatment arms.
Measured by the result of MELD score. Minimum MELD score: 6 points. Maximum MELD score: 40 points. Higher scores means a worse result.
Time frame: Through study completion, an average of 28 days
Evolution of score Child-Pugh in both treatment arms.
Measured by the result of Child -Pugh score. Minimum Child-Pugh score: 5 points. Maximum Child-Pugh score: 15 points. Higher scores means a worse result.
Time frame: Through study completion, an average of 28 days
Evolution of score CLIF-OF (Liver Failure Consortium - Organ Failure) in both treatment arms.
Measured by the result of CLIF-OF score. Minimum CLIF-OF score: 6 points. Maximum CLIF-OF score: 18 points. Higher scores means a worse result.
Time frame: Through study completion, an average of 28 days
Evolution of score CLIF-C AD (Chronic Liver Failure Consortium - non-ACLF patients with Acute Decompensation) in both treatment arms.
Measured by the result of CLIF-C AD score. Minimum CLIF-C AD score: 6 points. Maximum CLIF-C AD score: 18 points. Higher scores means a worse result.
Time frame: Through study completion, an average of 28 days
Evolution of score CLIF-C ACLF (Chronic Liver Failure Consortium - Acute-on-Chronic Liver Failure) in both treatment arms.
Measured by the result of CLIF-C ACLF score. Minimum CLIF-C ACLF score: 6 points. Maximum CLIF-C ACLF score: 18 points. Higher scores means a worse result.
Time frame: Through study completion, an average of 28 days
Days of admission to the ICU if needed.
Measured by the days of admission to the ICU.
Time frame: Through study completion, an average of 28 days
Days of life support (dialysis, vasopressors, and mechanical ventilation) if needed.
Measured by the days of life support.
Time frame: Through study completion, an average of 28 days
Days of hospital stay
Measured by the days of hospital stay.
Time frame: Through study completion, an average of 28 days
Number of rehospitalizations.
Measured by the number of rehospitalizations.
Time frame: Through study completion, an average of 28 days
Antibiotics consumption
Measured by the days of antibiotics consumption.
Time frame: Through study completion, an average of 28 days
Antibiotics consumption
Measured by dose of antibiotics.
Time frame: Through study completion, an average of 28 days.
Antibiotics consumption
Measured by type of antibiotics.
Time frame: Through study completion, an average of 28 days
Health costs
Measured by the cost of antibiotic, cost of hospital/ICU stay and of organ support(s).
Time frame: Through study completion, an average of 28 days
Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
Measured by the number of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs.
Time frame: Through study completion, an average of 28 days
Hospital survival
Number of survival participants
Time frame: During hospitalization (until discharge), assessed up to day 28.
28-day survival
Number of survival participants
Time frame: 28 days