Randomized controlled trial comparing conventional antibiotic strategies versus regimens guided by epidemiological surveillance in infected patients with cirrhosis.

Conditions

diagnosed with bacterial infection evolution lasting for 48 hours or less., Hospitalized patients with decompensated cirrhosis

Brief summary

Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days (composite variable: MDRO colonization and/or infection).

Detailed description

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., Days of admission to the ICU if needed., Days of life support (dialysis, vasopressors, and mechanical ventila- tion) if needed., Days of hospital stay., Number of rehospitalizations., Antibiotics consumption (days, dose and type of antibiotics) and health costs (cost of antibiotic, cost of hospital/ICU stay and of organ support(s))., Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs., Hospital and 28-day survival.

Related papers

No related papers found yet.

Interventions

DRUGNorfloxacino Sandoz 400 mg comprimidos EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Probability/rate of participants of developing antibiotic resistance in both treatment arms at 28 days (composite variable: MDRO colonization and/or infection).	—

Secondary

Measure	Time frame
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., Days of admission to the ICU if needed., Days of life support (dialysis, vasopressors, and mechanical ventila- tion) if needed., Days of hospital stay., Number of rehospitalizations., Antibiotics consumption (days, dose and type of antibiotics) and health costs (cost of antibiotic, cost of hospital/ICU stay and of organ support(s))., Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs., Hospital and 28-day survival.	—

Measure

Time frame

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., Days of admission to the ICU if needed., Days of life support (dialysis, vasopressors, and mechanical ventila- tion) if needed., Days of hospital stay., Number of rehospitalizations., Antibiotics consumption (days, dose and type of antibiotics) and health costs (cost of antibiotic, cost of hospital/ICU stay and of organ support(s))., Proportion of participants with antibiotic-related AE, SAEs, SUSARs and other SAEs., Hospital and 28-day survival.

—

Countries

Spain

Outcome results

None listed