Evidence map›Paper›PMID 29570857›Full record

ReviewMycoses2018

Isavuconazole treatment for rare fungal diseases and for invasive aspergillosis in patients with renal impairment: Challenges and lessons of the VITAL trial.

John R Perfect, Oliver A Cornely, Markus Heep, Luis Ostrosky-Zeichner, Kathleen M Mullane, Rochelle Maher, Rodney Croos-Dabrera, Christopher Lademacher, Marc Engelhardt, Caroline Chen and 1 more

Open access · hybridAbstract readReview
In one paragraph

Review in Mycoses, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

15 citing papers in PubMed, 30 citations in OpenAlex.

  1. Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  2. Trial
  3. Real-world study of effectiveness and safety compared among isavuconazole, amphotericin B, and voriconazole in invasive mold disease patients.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026
    Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Therapeutic Approaches for CombatingCurrent drug targets · 2022
    Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Treatment of Aspergillosis.Journal of fungi (Basel, Switzerland) · 2018
    Review
  15. Article
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

11 authors at 7 institutions in 3 countries.

John R PerfectDivision of Infectious Diseases, Department of Medicine, Duke University, Durham, NC, USA.ORCID http://orcid.org/0000-0002-8742-3676
Oliver A CornelyDepartment I of Internal Medicine, Clinical Trials Centre Cologne, ZKS Köln, Cologne, Germany.ORCID http://orcid.org/0000-0001-9599-3137
Markus HeepBasilea Pharmaceutica International Ltd, Basel, Switzerland.
Luis Ostrosky-ZeichnerUniversity of Texas Medical School at Houston, Houston, TX, USA.
Kathleen M MullaneDepartment of Medicine, Section of Infectious Diseases and Global Health, University of Chicago, Chicago, IL, USA.
Rochelle MaherAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Rodney Croos-DabreraAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Christopher LademacherAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Marc EngelhardtBasilea Pharmaceutica International Ltd, Basel, Switzerland.
Caroline ChenAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Francisco M MartyDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA.ORCID http://orcid.org/0000-0002-3708-8734
Astellas Pharma (United States) · USBasilea Pharmaceutica (Switzerland) · CHBrigham and Women's Hospital · USChicago Department of Public Health · USDuke University · USTexas Medical Center · USUniversity of Cologne · DE

Funding

Trehalose Pathway for Antifungal Targets and InhibitorsP01AI104533 · NIAID · DUKE UNIVERSITY · PI PERFECT, JOHN R. · 2015 to 2019
$9.0M
Pathobiology of C. neoformans in the Central Nervous SystemR01AI073896 · NIAID · DUKE UNIVERSITY · PI PERFECT, JOHN R. · 2008 to 2018
$4.4M
GENTIC &MOLECULAR BIOLOGY OF VIRULENCE IN C. NEOFORMANSR01AI028388 · NIAID · DUKE UNIVERSITY · PI PERFECT, JOHN R. · 1991 to 2004
$1.9M
NIAID NIH HHS P01 AI104533NIAID NIH HHS R01 AI028388NIAID NIH HHS R01 AI073896
6 · The paper itself

Abstract

Invasive fungal disease (IFD) confers a substantial risk for morbidity and mortality to immunocompromised patients. Invasive aspergillosis (IA) is the most common IFD caused by moulds but the prevalence of other rare mould diseases, such as mucormycosis, hyalohyphomycosis and phaeohyphomycosis, may be increasing. Treatments are available for IA, but evidence to support efficacy and safety of antifungal agents for rare IFDs, or for IFDs in special patient populations, is limited or lacking. The VITAL trial was conducted to assess the efficacy and safety of isavuconazole for the treatment of patients with IA and renal impairment, or with IFDs caused by rare moulds, yeasts or dimorphic fungi. These patients stand to benefit most from a new treatment option but are unlikely to be included in a randomised, controlled trial. In this article, we review the challenges faced in the design and conduct of the VITAL trial. We also review the findings of VITAL, which included evidence of the efficacy and safety of isavuconazole. Finally, we consider the importance of trials such as VITAL to inform therapeutic decision making for clinicians faced with the challenge of treating patients with rare IFDs and as one paradigm of how to determine efficacy and safety of new drugs for rare and resistant infections without a suitable comparator.

Indexed as

Randomized Controlled Trials as TopicAdultAntifungal AgentsFungiHumansImmunocompromised HostInvasive Fungal InfectionsInvasive Pulmonary AspergillosisMiddle AgedMucormycosisMycosesNitrilesPyridinesRare DiseasesRenal InsufficiencyTriazolesAntifungal AgentsisavuconazoleNitrilesPyridinesTriazolesaspergillosiscryptococcosisdimorphic fungiinvasive fungal diseasesisavuconazolemucormycosisrare mouldsyeasts

Identifiers

PMID29570857
PMCPMC6490690
OpenAlexW2794293219

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.