Evidence map›Paper›PMID 38943088›Full record

ArticleBMC infectious diseases2024

Adverse events during intravenous fosfomycin therapy in a real-life scenario. Risk factors and the potential role of therapeutic drug monitoring.

Simona Biscarini, Davide Mangioni, Chiara Bobbio, Ludovica Mela, Laura Alagna, Sara Baldelli, Francesco Blasi, Ciro Canetta, Ferruccio Ceriotti, Andrea Gori and 5 more

Abstract read
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Observational
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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

15 authors.

Simona Biscarini *Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.
Davide Mangioni *Infectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy. davide.mangioni@policlinico.mi.it.
Chiara BobbioInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.
Ludovica MelaInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.
Laura AlagnaInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.
Sara BaldelliPharmacology Unit, Clinical Chemistry Laboratory, ASST Spedali Civili di Brescia, Brescia, Italy.
Francesco BlasiRespiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore, Policlinico, Milan, Italy.
Ciro CanettaAcute Medical Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Ferruccio CeriottiClinical Laboratory, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Andrea GoriDepartment of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Giacomo GrasselliDepartment of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Bianca MarianiInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.
Antonio MuscatelloInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.
Dario CattaneoDepartment of Infectious Diseases, ASST-Fatebenefratelli Sacco University Hospital, Milan, Italy.
Alessandra BanderaInfectious Diseases Unit, IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation, Via Francesco Sforza 35, Milan, 20122, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntravenous fosfomycin (IVFOF) is gaining interest in severe infections. Its use may be limited by adverse events (AEs). Little experience exists on IVFOF therapeutic drug monitoring (TDM) in real-life setting. PATIENTS AND

methodsRetrospective study of patients receiving IVFOF for > 48 h at Policlinico Hospital (Milan, Italy) from 01/01/2019 to 01/01/2023. AEs associated to IVFOF graded CTCAE ≥ II were considered. Demographic and clinical risk factors for IVFOF-related AEs were analysed with simple and multivariable regression models. The determination of IVFOF TDM was made by a rapid ultraperformance liquid chromatography mass spectrometry method (LC-MS/MS) on plasma samples. The performance of TDM (trough levels (Cmin) in intermittent infusion, steady state levels (Css) in continuous infusion) in predicting AEs ≤ 5 days after its assessment was evaluated.

resultsTwo hundred and twenty-four patients were included. At IVFOF initiation, 81/224 (36.2%) patients were in ICU and 35/224 (15.7%) had septic shock. The most frequent infection site was the low respiratory tract (124/224, 55.4%). Ninety-five patients (42.4%) experienced ≥ 1AEs, with median time of 4.0 (2.0-7.0) days from IVFOF initiation. Hypernatremia was the most frequent AE (53/224, 23.7%). Therapy discontinuation due to AEs occurred in 38/224 (17.0%). ICU setting, low respiratory tract infections and septic shock resulted associated with AEs (RR

conclusionsWe provided real world data on the use of IVFOF-based regimens and associated AEs. IVFOF TDM deserves further research as it may represent a valid tool to predict AEs. KEY POINTS: Real world data on intravenous fosfomycin for severe bacterial infections. AEs occurred in over 40% (therapy discontinuation in 17%) and were related to baseline clinical severity but not to fosfomycin dose. TDM showed promising results in predicting AEs.

Indexed as

Anti-Bacterial AgentsDrug MonitoringFosfomycinAdministration, IntravenousAdultAgedFemaleHumansItalyMaleMiddle AgedRetrospective StudiesRisk FactorsTandem Mass SpectrometryAnti-Bacterial AgentsFosfomycinAdverse eventsAntimicrobial resistanceIntravenous fosfomycin disodiumMultidrug resistanceTDMToxicity

Identifiers

PMID38943088
PMCPMC11212171

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Registered trials

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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.