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
- Registration Number
- 2024-514042-36-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 340
Age ≥ 18 years
Admitted in one of the participating ICU
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
Pregnancy and breastfeeding
Myasthenia gravis
Concomitant administration of intravenous Polymyxin - Delay between onset of sepsis and inclusion>24 hours
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
Contraindication to aminoglycosides as mentioned in SpC section 4.3
Hypersensitivity to amikacin, to other antibiotics from the aminoglycoside family, or to any excipient from the amikacin used
Patients with documented allergy to aminoglycosides
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Day-90 mortality Day-90 mortality
- Secondary Outcome Measures
Name Time Method Day-28 and hospital mortality Day-28 and hospital mortality
Incidence and severity of AKI according to KDIGO definition 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) 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 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 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 selected serious adverse events including unexpected cardiac arrest
Incidence density of new bacterial, viral or fungal episode 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 Number of days free from organ support therapy (mechanical ventilation, vasopressors or RRT) at day 28
Rate of clinical cure Rate of clinical cure
Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation. Frequency of initial antibiotic therapy inadequate as regard to microbiological documentation.
Number of day free of antibiotic therapy at day-28 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 Duration of aminoglycoside therapy, rate of aminoglycoside overdosage according to residual concentration and overuse when compared to experts recommendations
Related Research Topics
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Trial Locations
- Locations (7)
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Centre Hospitalier Universitaire D'Angers
🇫🇷Angers, France
Hospices Civils De Lyon
🇫🇷Lyon Cedex 03, France
University Hospital Of Clermont-Ferrand
🇫🇷Clermont Ferrand Cedex 1, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷Saint Priest En Jarez, France
Centre Hospitalier De Versailles
🇫🇷Le Chesnay Rocquencourt, France
Centre Hospitalier Universitaire De Lille
🇫🇷Lille Cedex, France
Assistance Publique Hopitaux De Paris🇫🇷Paris, FranceFrédéric PENESite contact0158412517frederic.pene@aphp.frThomas URBINASite contact0149282000thomas.urbina@aphp.frMaxens DECAVELLESite contact0184827939maxens.decavele@aphp.frMichael DARMONSite contact0142499222michael.darmon@aphp.fr