Weekly high-dose liposomal amphotericin B L-AmB in critically ill septic patients with multiple Candida colonization: The AmBiDex studyReport as inadecuate




Weekly high-dose liposomal amphotericin B L-AmB in critically ill septic patients with multiple Candida colonization: The AmBiDex study - Download this document for free, or read online. Document in PDF available to download.

Background

To demonstrate the feasibility and safety of weekly high-dose liposomal amphotericin B L-AmB as a pre-emptive antifungal treatment for 2 weeks in patients with septic shock and Candida colonization.

Methods

Pilot, multicentre, open-label, prospective study conducted in seven French ICUs. Non-immunocompromised patients, receiving mechanical ventilation were eligible if they presented ICU-acquired severe sepsis requiring newly administered antibacterial agents and Candida colonization in at least two sites. Exclusion criteria included the need for antifungal therapy and creatinine > 220 μmol-L. All patients were to receive a high-dose L-AmB 10 mg-kg-week for two weeks. A follow-up period of 21 days following the second administration of L-AmB was conducted. Treated patients were compared to 69 matched untreated controls admitted in the same ICUs before the study period.

Results

Twenty-one patients were included in the study, of which 20 received at least one infusion of high-dose L-AmB. A total of 24 adverse events were identified in 1361% patients. Fourteen adverse events were categorized as serious in 838% patients. In four cases the adverse events were considered as potentially related to study drug administration and resulted in L-AmB discontinuation in one patient. Few patients experienced severe renal toxicity since no patient presented with severe hypokalemia. No patients required renal replacement therapy. Compared to matched controls, no significant increase in serum creatinine levels in patients receiving high-dose L-AmB was reported.

Conclusions

Weekly administration of high-dose L-AmB has a manageable safety profile and is feasible in patients with ICU-acquired sepsis and multiple Candida colonization. Trials of L-AmB versus other antifungal agents used as pre-emptive antifungal therapy are warranted.

Trial registration

ClinicalTrials.gov NCT00697944



Author: Elie Azoulay , Jean-François Timsit, Alexandre Lautrette, Stephane Legriel, Adeline Max, Stephane Ruckly, Benoit Misset, Yves Co

Source: http://plos.srce.hr/



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