Evidence map›Paper›PMID 41400786›Full record

ArticleMycopathologia2025

Therapeutic Drug Monitoring of Itraconazole in Endemic Paracoccidioidomycosis: Real-World Data.

Wdson Luis Lima Kruschewsky, Vera Lucia Teixeira de Freitas, Mariane Taborda, Isabela Antonini Alves Oliveira Quadros, Mônica Scarpelli Martinelli Vidal, Tiago Alexandre Cocio, Gil Benard, Nilo José Coêlho Duarte, Vítor Falcão de Oliveira, Adriana Satie Gonçalves Kono Magri and 1 more

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Article in Mycopathologia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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2citing 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.

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

2 citing papers in PubMed.

  1. Article
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4 · The record

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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

11 authors.

Wdson Luis Lima KruschewskyInfectious Diseases and Tropical Medicine Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. wdsonkruschewsky@gmail.com.
Vera Lucia Teixeira de FreitasLaboratory of Medical Imunology-LIM48, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Instituto de Medicina Tropical, São Paulo, Brazil.
Mariane TabordaInfectious Diseases and Tropical Medicine Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Isabela Antonini Alves Oliveira QuadrosInfectious Diseases and Tropical Medicine Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Mônica Scarpelli Martinelli VidalLaboratory of Medical Mycology-LIM53, Instituto de Medicina Tropical/Division of Clinical Dermatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Tiago Alexandre CocioLaboratory of Medical Mycology-LIM53, Instituto de Medicina Tropical/Division of Clinical Dermatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Gil BenardLaboratory of Medical Mycology-LIM53, Instituto de Medicina Tropical/Division of Clinical Dermatology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Nilo José Coêlho DuarteCentral Laboratory Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Vítor Falcão de OliveiraInfectious Diseases and Tropical Medicine Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Adriana Satie Gonçalves Kono MagriInfectious Diseases and Tropical Medicine Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Marcello Mihailenko Chaves MagriInfectious Diseases and Tropical Medicine Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTherapeutic drug monitoring (TDM) of itraconazole (ITC) has been recommended by international guidelines to optimize efficacy and reduce toxicity, especially in the context of invasive fungal infections. However, whether the same therapeutic targets apply to paracoccidioidomycosis (PCM) remains uncertain.

methodsWe conducted a retrospective analysis of patients with proven or probable PCM who used ITC during antifungal treatment between 2016 and 2024 at the University of São Paulo. Two groups were formed: the TDM group and the non-TDM group. Serum samples were obtained at steady-state (≥ 7 days after treatment initiation), and ITC levels were measured by liquid chromatography-mass spectrometry (LC-MS/MS). The institutional standard treatment was ITC capsules at 200 mg once or twice daily, depending on disease severity. Therapeutic serum trough concentrations were defined as 0.5-4.0 mg/L.

resultsEighty-three patients were included, 18 in the TDM group and 65 in the non-TDM group, predominantly middle-aged males (median age 53 years; 70% male) with the chronic form of PCM (84%). Only 44.4% of initial serum concentrations were within the therapeutic range. Notably, 22% of patients had undetectable serum levels (< 0.014 mg/L). The median ITC concentration was 0.26 mg/L (IQR 0.04-1.95), and no toxic levels were observed. No statistically significant differences were found between the groups regarding ITC dose modification, drug interactions, toxicity, or duration of therapy.

conclusionSubtherapeutic serum ITC concentrations were common among PCM patients receiving capsule formulations. Although clinical response was generally favorable, the high variability in absorption highlights the potential value of TDM in selected cases. Prospective studies are warranted to define optimal target levels for PCM management.

Indexed as

Antifungal AgentsDrug MonitoringItraconazoleParacoccidioidomycosisAdultAgedBrazilChromatography, LiquidEndemic DiseasesFemaleHumansMaleMiddle AgedRetrospective StudiesTandem Mass SpectrometryYoung AdultAntifungal AgentsItraconazoleAntifungal therapyItraconazoleParacoccidioidomycosisTherapeutic drug monitoring

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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.