Evidence map›Paper›PMID 27169478›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses.

George R Thompson, Adrian Rendon, Rodrigo Ribeiro Dos Santos, Flavio Queiroz-Telles, Luis Ostrosky-Zeichner, Nkechi Azie, Rochelle Maher, Misun Lee, Laura Kovanda, Marc Engelhardt and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00634049 (Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi), which is not on this map. Cited by 93 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 4 pooled it
21.0field-weighted citation impact, top 1% 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.

NCT00634049 phase3completednot on this map

Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

TypeinterventionalSponsorAstellas Pharma IncRan2008 to 2016Enrolled149ConditionsAspergillosis, Invasive Fungal InfectionsArmsisavuconazole
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 4 syntheses or guidelines pooled it, 211 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Treating progressive disseminated histoplasmosis in people living with HIV.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Drug Discovery and Repurposing forJournal of fungi (Basel, Switzerland) · 2025
    Review
  13. Article
  14. Article
  15. Histoplasmosis.Infectious disease clinics of North America · 2025
    Review
  16. Optimizing antifungal dosing for invasiveFrontiers in pharmacology · 2025
    Article
  17. Review
  18. Article
  19. ISCCM Position Statement on the Management of Invasive Fungal Infections in the Intensive Care Unit.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024
    Article
  20. Review

33 more citing papers are in PubMed but not listed here.

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

13 authors at 10 institutions in 5 countries.

George R ThompsonDepartment of Medicine/Division of Infectious Diseases, University of California-Davis Medical Center, Sacramento.
Adrian RendonCIPTIR, Universidad Autónoma de Nuevo León, Monterrey, México.
Rodrigo Ribeiro Dos SantosUniversidade Federal de Minas Gerais, Santa Casa de Belo Horizonte.
Flavio Queiroz-TellesDepartment of Public Health Hospital de Clínicas, Federal University of Paraná, Curitiba, Brazil.
Luis Ostrosky-ZeichnerUniversity of Texas Medical School at Houston and Memorial Hermann-Texas Medical Center.
Nkechi AzieAstellas Pharma Global Development, Inc, Northbrook, Illinois.
Rochelle MaherAstellas Pharma Global Development, Inc, Northbrook, Illinois.
Misun LeeAstellas Pharma Global Development, Inc, Northbrook, Illinois.
Laura KovandaAstellas Pharma Global Development, Inc, Northbrook, Illinois.
Marc EngelhardtBasilea Pharmaceutica International Ltd, Basel, Switzerland.
Jose A VazquezDepartment of Medicine, Division of Infectious Diseases, Medical College of Georgia/Georgia Regents University, Augusta.
Oliver A CornelyDepartment of Internal Medicine, Clinical Trials Centre Cologne, ZKS Köln, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Germany.
John R PerfectDepartment of Medicine/Division of Infectious Diseases, Duke University, Durham, North Carolina.
Astellas Pharma (United States) · USAugusta University · USBasilea Pharmaceutica (Switzerland) · CHDuke University Hospital · USHospital de Clínicas Universidade Federal do Paraná · BRMemorial Hermann–Texas Medical Center · USUniversidad Autónoma de Nuevo León · MXUniversidade Federal de Minas Gerais · BRUniversity of California Davis Medical Center · USUniversity of Cologne · DE

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

backgroundInvasive fungal diseases (IFD) caused by Cryptococcus and dimorphic fungi are associated with significant morbidity and mortality. Isavuconazole (ISAV) is a novel, broad-spectrum, triazole antifungal agent (IV and by mouth [PO]) developed for the treatment of IFD. It displays potent activity in vitro against these pathogens and in this report we examine outcomes of patients with cryptococcosis or dimorphic fungal infections treated with ISAV.

methodsThe VITAL study was an open-label nonrandomized phase 3 trial conducted to evaluate the efficacy and safety of ISAV treatment in management of rare IFD. Patients received ISAV 200 mg 3 times daily for 2 days followed by 200 mg once-daily (IV or PO). Proven IFD and overall response at end of treatment (EOT) were determined by an independent, data-review committee. Mortality and safety were also assessed.

resultsThirty-eight patients received ISAV for IFD caused by Cryptococcus spp. (n = 9), Paracoccidioides spp. (n = 10), Coccidioides spp. (n = 9), Histoplasma spp. (n = 7) and Blastomyces spp. (n = 3). The median length of therapy was 180 days (range 2-331 days). At EOT 24/38 (63%) patients exhibited a successful overall response. Furthermore, 8 of 38 (21%) had stable IFD at the end of therapy without progression of disease, and 6 (16%) patients had progressive IFD despite this antifungal therapy. Thirty-three (87%) patients experienced adverse events.

conclusionsISAV was well tolerated and demonstrated clinical activity against these endemic fungi with a safety profile similar to that observed in larger studies, validating its broad-spectrum in vitro activity and suggesting it may be a valuable alternative to currently available agents. CLINICAL TRIALS REGISTRATION: NCT00634049.

Indexed as

AdultAgedAntifungal AgentsBlastomycosisCoccidioidomycosisCryptococcosisFemaleHistoplasmosisHumansMaleMiddle AgedMycosesNitrilesParacoccidioidomycosisPyridinesTriazolesAntifungal AgentsisavuconazoleNitrilesPyridinesTriazolesblastomycosiscoccidioidomycosiscryptococcosishistoplasmosisparacoccidioidomycosis

Identifiers

PMID27169478
PMCPMC4946023
OpenAlexW2357730895

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.