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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
EU CTIS ID: 2024-514042-36-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.