Evidence map›Paper›PMID 28531175›Full record

ArticlePloS one2017

Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study.

Elie Azoulay, Jean-François Timsit, Alexandre Lautrette, Stephane Legriel, Adeline Max, Stephane Ruckly, Benoit Misset, Yves Cohen, Michel Wolff

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00697944 (Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00697944 phase4unknown statusnot on this map

Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

TypeinterventionalSponsorFoveaRan2008 to 2009Enrolled30ConditionsSepsis, CandidaArmsAmphotericine in liposome (Ambisome®)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Amphotericin B in the Era of New Antifungals: Where Will It Stand?Journal of fungi (Basel, Switzerland) · 2024
    Review
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Elie AzoulayMedical ICU, Saint Louis University Hospital, Paris, France.
Jean-François TimsitMedical and Infectious Diseases ICU, Paris Diderot University/Bichat Hospital, Paris, France.
Alexandre LautretteMedical ICU, Gabriel-Montpied University Hospital, Clermont-Ferrand, France.
Stephane LegrielMedico-surgical ICU, Versailles Hospital, Le Chesnay, France.ORCID http://orcid.org/0000-0003-4782-6734
Adeline MaxMedical ICU, Saint Louis University Hospital, Paris, France.
Stephane RucklyDepartment of Biostatistics, OUTCOMEREATM, Bobigny, France.
Benoit MissetMedical ICU, Saint Joseph University Hospital, Paris, France.
Yves CohenMedical ICU, Avicenne University Hospital, Bobigny, France.
Michel WolffMedical and Infectious Diseases ICU, Paris Diderot University/Bichat Hospital, Paris, France.
Délégation Paris 7 · FRCentre Hospitalier de Versailles · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FREquipe de Recherche en Epidémiologie Nutritionnelle · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo 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.

methodsPilot, 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.

resultsTwenty-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 13(61%) patients. Fourteen adverse events were categorized as serious in 8(38%) 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.

conclusionsWeekly 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 registrationClinicalTrials.gov NCT00697944.

Indexed as

AgedAmphotericin BAntifungal AgentsCandidaCandidiasisCritical IllnessCross InfectionFemaleHumansIntensive Care UnitsMaleMiddle AgedPilot ProjectsProspective StudiesSepsisTreatment OutcomeAmphotericin BAntifungal Agentsliposomal amphotericin B

Identifiers

PMID28531175
PMCPMC5439673
OpenAlexW2617745014

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.