Evidence map›Paper›PMID 34845574›Full record

ArticlePharmaceutical research2021

Micafungin Population PK Analysis in Healthy and Septic Pigs: Can the Septic Porcine Model Predict the Micafungin PK in Septic Patients?

Nicolas Garbez, Litaty C Mbatchi, Guillaume Louart, Steven C Wallis, Laurent Muller, Jeffrey Lipman, Jason A Roberts, Jean-Yves Lefrant, Claire Roger

Registry-linked trialAbstract read
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In one paragraph

Article in Pharmaceutical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04178148 (Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock), which is not on this map. Not yet cited in PubMed.

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0citing papers in PubMed
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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.

NCT04178148 nacompletednot on this map

Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock

TypeinterventionalSponsorCentre Hospitalier Universitaire de NīmesRan2019 to 2022Enrolled180ConditionsShock, SepticArmsAmikacin dose optimization
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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 3 institutions in 3 countries.

Nicolas GarbezService Des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, Nîmes, France. nicolas.garbez@umontpellier.fr.ORCID http://orcid.org/0000-0002-8338-5385
Litaty C MbatchiLaboratoire de Pharmacocinétique, Faculté de Pharmacie, Université de Montpellier, Montpellier, France.
Guillaume LouartService Des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, Nîmes, France.
Steven C WallisUQ Centre for Clinical Research, The University of Queensland, Brisbane, QLD, Australia.
Laurent MullerService Des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, Nîmes, France.
Jeffrey LipmanUR-UM 103: IMAGINE (Initial Management And Prévention of orGan Failures IN Critically Ill patiEnts), Faculté de Médecine, Université de Montpellier, Montpellier, France.
Jason A RobertsUR-UM 103: IMAGINE (Initial Management And Prévention of orGan Failures IN Critically Ill patiEnts), Faculté de Médecine, Université de Montpellier, Montpellier, France.
Jean-Yves LefrantService Des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, Nîmes, France.
Claire RogerService Des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, Nîmes, France.
Université de Montpellier · FRThe University of Queensland · AUInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo describe micafungin pharmacokinetic (PK) alterations of sepsis induced in piglets and to determine whether the porcine septic model is able to predict the PK of micafungin in septic patients at the plasma and peritoneal sites.

methodsFrom healthy (n = 8) and septic piglet group (n = 16), total micafungin concentrations were subject to a population PK analysis using Monolix®. Data from 16 septic humans patients from others studies was used to compare micafungin PK between septic piglets and septic patients.

resultsSepsis induced in piglets slightly alters the total clearance and the volume of distribution, while inter-compartment clearance is increased (from 3.88 to 5.74 L/h) as well as the penetration into peritoneal cavity (from 61 to 90%). In septic human patients, PK parameters are similar except for the Vd, which is corrected by an allometric factor based on the body weight of each species. Micafungin penetration into peritoneal cavity of humans is lower than in septic piglets (40 versus 90%).

conclusionsThe sepsis induced in the porcine model alters the PK of micafungin comparable to that in humans. In addition, micafungin PK is similar between these two species at the plasma level taking into account the allometric relationship of the body weight of these species on the central volume of distribution. The porcine septic plasma model would be able to predict the micafungin PK in the septic patients. However, further studies on peritoneal penetration are necessary to characterize this inter-species difference.

Indexed as

AnimalsAntifungal AgentsBiological Variation, PopulationDisease Models, AnimalFemaleHumansMicafunginPeritoneumSepsisSpecies SpecificitySwineAntifungal AgentsMicafungincross-species extrapolationechinocandinspharmacokinetics modellingpiglet modelsepsis

Identifiers

PMID34845574
OpenAlexW3215858372

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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.