Evidence map›Paper›PMID 28289034›Full record

Trial reportAntimicrobial agents and chemotherapy2017

Impact of Mucositis on Absorption and Systemic Drug Exposure of Isavuconazole.

Laura L Kovanda, Francisco M Marty, Johan Maertens, Amit V Desai, Christopher Lademacher, Marc Engelhardt, Qiaoyang Lu, William W Hope

Open access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
4.0field-weighted citation impact, top 6% 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.

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

17 citing papers in PubMed, 68 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Definition and management of invasive fungal rhinosinusitis: a single-centre retrospective study.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2021
    Article
  11. Review
  12. Article
  13. Antimicrobial agents and chemotherapy · 2020
    Article
  14. A Single-Center, Open-Label Trial of Isavuconazole Prophylaxis against Invasive Fungal Infection in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2020
    Article
  15. Reply to Baud and Houzé, "ShouldAntimicrobial agents and chemotherapy · 2020
    Article
  16. A Review of the Clinical Pharmacokinetics and Pharmacodynamics of Isavuconazole.European journal of drug metabolism and pharmacokinetics · 2018
    Review
  17. Review
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

8 authors at 5 institutions in 4 countries.

Laura L KovandaAntimicrobial Pharmacodynamics and Therapeutics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.ORCID 0000-0002-4493-4652
Francisco M MartyBrigham and Women's Hospital, Boston, Massachusetts, USA.
Johan MaertensUniversitaire Ziekenhuizen, Leuven, Belgium.
Amit V DesaiAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Christopher LademacherAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Marc EngelhardtBasilea Pharmaceutica International Ltd., Basel, Switzerland.
Qiaoyang LuAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
William W HopeAntimicrobial Pharmacodynamics and Therapeutics, Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom william.hope@liverpool.ac.uk.
Astellas Pharma (United States) · USUniversity of Liverpool · GBBasilea Pharmaceutica (Switzerland) · CHBrigham and Women's Hospital · USUniversitair Ziekenhuis Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Isavuconazonium sulfate is the water-soluble prodrug of isavuconazole. Population analyses have demonstrated relatively predictable pharmacokinetic (PK) behavior in diverse patient populations. We evaluated the impact of mucositis on the oral isavuconazole exposure using population PK modeling. This study included patients treated in two phase 3 trials of isavuconazole, SECURE for treatment of invasive aspergillosis (IA) and other filamentous fungi and VITAL for patients with mucormycosis, invasive fungal disease (IFD) caused by other rare fungi, or IA and renal impairment. Mucositis was reported by site investigators and its impact on oral bioavailability was assessed. Use of the oral formulation was at the discretion of the investigator. Patients with plasma samples collected during the use of isavuconazonium sulfate were included in the construction of population PK model. Of 250 patients included, 56 patients had mucositis at therapy onset or as an adverse event during oral isavuconazole therapy. Levels of oral bioavailability were comparable, at 98.3% and 99.8%, respectively. The average drug exposures (average area under the curve [AUC

Indexed as

AdolescentAdultAgedAntifungal AgentsAspergillosisBiological AvailabilityFemaleHumansInvasive Fungal InfectionsMaleMiddle AgedMucormycosisMucositisNitrilesPyridinesTreatment OutcomeAntifungal AgentsisavuconazoleNitrilesPyridinesTriazolesantifungal agentsaspergillosisinvasive fungal diseasemucormycosismucositispopulation pharmacokineticstriazole

Identifiers

PMID28289034
PMCPMC5444187
OpenAlexW2597353500

What OpenQuestion holds

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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.