Evidence map›Paper›PMID 28923872›Full record

Trial reportAntimicrobial agents and chemotherapy2017

Exposure-Response Relationships for Isavuconazole in Patients with Invasive Aspergillosis and Other Filamentous Fungi.

Amit V Desai, Laura L Kovanda, William W Hope, David Andes, Johan W Mouton, Donna L Kowalski, Robert W Townsend, Salim Mujais, Peter L Bonate

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
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 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% 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

55 citing papers in PubMed, 1 synthesis or guideline pooled it, 112 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

9 authors at 4 institutions in 3 countries.

Amit V DesaiAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA amit.desai@astellas.com.
Laura L KovandaAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.ORCID 0000-0002-4493-4652
William W HopeUniversity of Liverpool, Liverpool, United Kingdom.ORCID 0000-0001-6187-878X
David AndesUniversity of Wisconsin, Madison, Wisconsin, USA.
Johan W MoutonErasmus MC, Rotterdam, The Netherlands.ORCID 0000-0001-6736-4149
Donna L KowalskiAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Robert W TownsendAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Salim MujaisAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Peter L BonateAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Astellas Pharma (United States) · USUniversity of Liverpool · GBErasmus MC · NLUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Isavuconazole, the active moiety of the water-soluble prodrug isavuconazonium sulfate, is a triazole antifungal agent for the treatment of invasive fungal infections. The purpose of this analysis was to characterize the isavuconazole exposure-response relationship for measures of efficacy and safety in patients with invasive aspergillosis and infections by other filamentous fungi from the SECURE clinical trial. Two hundred thirty-one patients who received the clinical dosing regimen and had exposure parameters were included in the analysis. The primary drug exposure parameters included were predicted trough steady-state plasma concentrations, predicted trough concentrations after 7 and 14 days of drug administration, and area under the curve estimated at steady state (AUCss). The exposure parameters were analyzed against efficacy endpoints that included all-cause mortality through day 42 in the intent-to-treat (ITT) and modified ITT populations, data review committee (DRC)-adjudicated overall response at end of treatment (EOT), and DRC-adjudicated clinical response at EOT. The safety endpoints analyzed were elevated or abnormal alanine aminotransferase, increased aspartate aminotransferase, and a combination of the two. The endpoints were analyzed using logistic regression models. No statistically significant relationship (

Indexed as

Alanine TransaminaseAntifungal AgentsAspartate AminotransferasesAspergillosisDose-Response Relationship, DrugDrug MonitoringHumansInvasive Fungal InfectionsNitrilesPyridinesTriazolesAlanine TransaminaseAntifungal AgentsAspartate AminotransferasesisavuconazoleNitrilesPyridinesTriazolesexposure-responseisavuconazoleSECURE clinical trialtriazole

Identifiers

PMID28923872
PMCPMC5700339
OpenAlexW2754519822

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.