neutropenic patients with sepsis
Conditions
Interventions
Trade Name: AMIKACINE
Product Name: AMIKACINE
Pharmaceutical Form: Powder for solution for injection
Sponsors
Assistance Publique – Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Sepsis or septic shock as defined by SEPSIS3 definition - Underlying tumor, allogeneic stem cell transplantation or hematological malignancy - Neutropenia (defined by either absolute neutrophil count =65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: - Pregnancy and breastfeeding - Moribund patients (death expected within 48 hours by attending physician) - Previous participation to this study - No affiliation to social security - Patients under legal protection according to French Law - Patient having received more than 1 injection of aminoglycosides in the 3 days preceding ICU admission - Hypersensitivity to amikacin, to other antibiotics from the aminoglycoside family, or to any excipient from the amikacin used. - Patients with documented allergy to aminoglycosides - Delay between admission for a new sepsis and inclusion>24 hours or (in patients previously admitted in the ICU for another reason) delay between new sepsis in study inclusion >24h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact on day-90 mortality of two strategies, separately, using a 2x2 factorial design RCT: •Intervention 1 - routine association of aminoglycoside to initial antibiotic therapy when compared to standard of care •Intervention 2 - lack of routine use of protective isolation when compared to standard of care ;Secondary Objective: To evaluate the impact of the studied interventions, on -Day-28 and hospital outcome -Incidence, severity and duration of AKI -Rate of adherence of hand hygiene -Rate of selected adverse events -Rate of nosocomial bacterial, viral and fungal infection episodes -Organ support during ICU stay and organ support duration -Failure of initial antibiotic therapy -Antibiotic duration -Rate of aminoglycosides overdosage and overuse ;Primary end point(s): Day-90 mortality ;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Day-28 and hospital mortality - Incidence and severity of AKI. - Major Adverse Kidney Events at day-28 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 ;Timepoint(s) of evaluation of this end point: NA | — |
Countries
France
Contacts
Public ContactKarine SEYMOUR
Assistance Publique – Hôpitaux de Paris
Outcome results
None listed