A

Phase 1

Active, not recruiting

Conditions: neutropenic patients with sepsis
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2019-003016-32-FR

Lead Sponsor: Assistance Publique – Hôpitaux de Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 340

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 <500/mm3 or leucocytes <1000/mm3) related to an underlying malignancy or its treatment
-Informed or deferred consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 255
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the impact on day-90 mortality of two strategies, separately, using a 2x2 factorial design RCT: <br>•Intervention 1 - routine association of aminoglycoside to initial antibiotic therapy when compared to standard of care<br>•Intervention 2 - lack of routine use of protective isolation when compared to standard of care<br>;Secondary Objective: To evaluate the impact of the studied interventions, on <br>-Day-28 and hospital outcome <br>-Incidence, severity and duration of AKI <br>-Rate of adherence of hand hygiene<br>-Rate of selected adverse events <br>-Rate of nosocomial bacterial, viral and fungal infection episodes<br>-Organ support during ICU stay and organ support duration<br>-Failure of initial antibiotic therapy <br>-Antibiotic duration<br>-Rate of aminoglycosides overdosage and overuse<br>;Primary end point(s): Day-90 mortality<br>;Timepoint(s) of evaluation of this end point: NA

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Day-28 and hospital mortality<br>- Incidence and severity of AKI.<br>- Major Adverse Kidney Events at day-28 and day 90.<br>- Rate of adherence to adequate hand hygiene as assessed by external observer.<br>- Incidence density of selected serious adverse events including unexpected cardiac arrest.<br>- Incidence density of new bacterial, viral or fungal episode.<br>- Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28<br>- Rate of clinical cure<br>- Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation.<br>- Number of day free of antibiotic therapy at day-28<br>- Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations<br>;Timepoint(s) of evaluation of this end point: NA