Combination lock01 - Impact of aminoglycosides-based antibiotics combination and protective isolation on outcomes in critically-ill neutropenic patients with sepsis:A randomized 2 by 2 factorial design randomized pragmatic trial

Conditions

Adult patients admitted to intensive care

Brief summary

Day-90 mortality

Detailed description

Day-28 and hospital mortality, Incidence and severity of AKI according to KDIGO definition, Major Adverse Kidney Events at day-28 and day 90 (composite of death, new renal replacement therapy, or persistent renal dysfunction), Incidence of clinically apparent loss of hearing at end of ICU stay and day 90, Rate of adherence to adequate hand hygiene as assessed by external observer, Incidence density of selected serious adverse events including unexpected cardiac arrest, Incidence density of new bacterial, viral or fungal episode, Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28, Rate of clinical cure, Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation., Number of day free of antibiotic therapy at day-28, Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations

Related papers

No related papers found yet.

Interventions

DRUGAMIKACIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Day-90 mortality	—

Secondary

Measure	Time frame
Day-28 and hospital mortality, Incidence and severity of AKI according to KDIGO definition, Major Adverse Kidney Events at day-28 and day 90 (composite of death, new renal replacement therapy, or persistent renal dysfunction), Incidence of clinically apparent loss of hearing at end of ICU stay and day 90, Rate of adherence to adequate hand hygiene as assessed by external observer, Incidence density of selected serious adverse events including unexpected cardiac arrest, Incidence density of new bacterial, viral or fungal episode, Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28, Rate of clinical cure, Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation., Number of day free of antibiotic therapy at day-28, Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations	—

Measure

Time frame

Day-28 and hospital mortality, Incidence and severity of AKI according to KDIGO definition, Major Adverse Kidney Events at day-28 and day 90 (composite of death, new renal replacement therapy, or persistent renal dysfunction), Incidence of clinically apparent loss of hearing at end of ICU stay and day 90, Rate of adherence to adequate hand hygiene as assessed by external observer, Incidence density of selected serious adverse events including unexpected cardiac arrest, Incidence density of new bacterial, viral or fungal episode, Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28, Rate of clinical cure, Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation., Number of day free of antibiotic therapy at day-28, Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations

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Countries

France

Outcome results

None listed