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AspergillosisPhase 3VITALNCT00634049

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

A Phase 3 study testing isavuconazole in people with Aspergillosis and Invasive Fungal Infections, run by Astellas Pharma Inc at 96 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aspergillosis, Invasive Fungal Infections
What is being tested?
isavuconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
96 sitesin 19 countries
Study dates
22 Apr 2008to 5 May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • •Participants meeting EORTC/MSG (European Organization for the Research and Treatment of Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD (invasive fungal disease) caused by rare moulds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment.
  • OR
  • •Participants who had proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.
  • OR
  • •Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were refractory to current treatment defined as,
  • Clear documentation of progression of disease. Note: radiological progression only in association with white blood cell (WBC) count recovery was not acceptable.
Show all 13Show fewer
  • Failure to improve clinically despite receiving at least 7 days of standard antifungal regimen. Prior to enrolling patients who fell into this category, the Medical Monitor was contacted for approval.
  • OR
  • Participants meeting EORTC/MSG definition of proven or culture positive probable IFD caused by rare moulds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus fumigatus or Candida species), whether RI or not (including dialysis), who were intolerant to current treatment for example:
  • Doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours.
  • Serum creatinine > 2.0 mg/mL and current treatment with polyene or IV voriconazole.
  • Other significant drug-related adverse reaction(s) to the current antifungal agent, resulting in discontinuation of the treatment, e.g., persistence of visual disturbance, allergic reaction, phototoxicity or severe infusion reaction (hypertensive crisis, severe chills or shock).
  • Documented inability to achieve adequate blood levels of posaconazole, voriconazole or itraconazole.

Who cannot join

  • A known condition of the participants that may jeopardize adherence to the protocol requirements
  • Participants who are unlikely to survive 30 days
  • Participants with a body weight < 40 kg
  • Women who are pregnant or breastfeeding

Trial locations and contacts

96 sites in 19 countries.

96 sites in 19 countries

United States24 sites

  • Upstate Infectious Diseases Association LLP

    Albany, New York, 12208

  • Emory Hospital

    Atlanta, Georgia, 30322

  • University Of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Indiana BMT

    Beech Grove, Indiana, 46107

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham & Womens Hospital

    Boston, Massachusetts, 02115

  • University of Chicago, Division of Infectious Diseases

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City Of Hope National Medical Center

    Duarte, California, 91010

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Infectious Disease of Indiana

    Indianapolis, Indiana, 46280

  • Regional Infection Diseases Infusion Center Inc.

    Lima, Ohio, 45801

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Temple University Health Sciences

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15213

  • University of California Davis Health System

    Sacramento, California, 95817

  • California Pacific Medical Center

    San Francisco, California, 94110

  • University of California at San Francisco

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Research Center, Clinical Research

    Seattle, Washington, 98109

  • Stanford University Hospital

    Stanford, California, 94303

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

India8 sites

  • Sterling Hospital

    Ahmedabad, 380052

  • Global Hospitals & Health City

    Chennai, Tamilna, 600100

  • Medanta Medicity Hospital

    Gūrgaon, Haryan, 122001

  • Apollo Hospitals

    Hyderabad, 500033

  • Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

    Manipal, Kama, 576104

  • Tata Memorial Hopital, Department of Anesthesia

    Mumbai, Mahara, 400012

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Mahara, 411004

  • Sahyadri Specialty Hospital

    Pune, 411004

Other trials in India

Brazil7 sites

  • Hospital Felicio Rocho

    Belo Horizonte, 30110-908

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Hospital das Clinicas da UFPR

    Curitiba, 80060-150

  • Hospital de Clinicas da FMUSP - Ribeirao Preto

    Ribeirão Preto, 14048-900

  • Hospital Universitario Clementino Fraga Filho

    Rio de Janeiro, 21941-913

  • Hospital Universitario de Santa Maria

    Santa Maria, 97105-900

  • Hospital Professor Edmundo Vasconcelos

    São Paulo, 04038-905

Other trials in Brazil

France6 sites

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Institut Paoli Calmette - Marseille

    Marseille, 13273

  • Hotel Dieu

    Nantes, 44093

  • Hôpital Saint-Louis

    Paris, 75475

  • Hopital Hautepierre

    Strasbourg, 67048

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Argentina5 sites

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma, 1181

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma, 1426

  • Hospital Nuestra Senora de la Misericordia

    Córdoba, 5000

  • Hospital San Roque

    Córdoba, 5000

  • Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

    San Juan, 5402

Other trials in Argentina

Germany5 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Charite-Campus Benjamin Franklin

    Berlin, 12200

  • Universitaet Koeln

    Cologne, 50931

  • Klinikum Neuperlach

    München, 81737

  • Medizinische Klinik und Polyklinik II

    Würzburg, 97080

Other trials in Germany

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah Universtiy Hospital - Ein Kerem

    Jerusalem, 91200

  • Rabin MC

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Sourasky MC Ichilov Hospital Tel Aviv

    Tel Aviv, 64239

Other trials in Israel

South Korea5 sites

  • Soonchunhyang University Bucheon Hospital

    Buchon-si, 420-767

  • Gachon University Gil Hospital

    Incheon, 405-760

  • Samsung Medical Center

    Seoul, 135-710

  • The Catholic University of Korea

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Thailand5 sites

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Maharat Nakhon Ratchasima Hospital

    Muang, 30000

  • Srinagarind Hospital

    Muang, 40002

  • Maharaj Nakorn Chiang Mai Hospital

    Muang, 50200

  • Ramathibodi Hospital

    Ratchathewi, 10400

Other trials in Thailand

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Erasme Hospital

    Brussels, 1070

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

Other trials in Belgium

Mexico4 sites

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador

    Mexico City, 14000

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Hospital Central Dr Ignacio Morones Prieto

    San Luis Potosí City, 78240

Other trials in Mexico

Russia4 sites

  • S.I. Russian Oncological Research Center n.a. N.N. Blokhin

    Moscow, 115478

  • State Institution "Hematology Research Center" RAMS

    Moscow, 125167

  • Republican Hospital named after V.A. Baranov

    Petrozavodsk, 185019

  • St-Petersburg MA Postgraduate Education

    Saint Petersburg, 194291

Other trials in Russia

Canada3 sites

  • Hamilton Health Sciences - Henderson Site

    Hamilton, Ontario, L8V 1C3

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Egypt3 sites

  • Alexandria University Hospital

    Alexandria, 21131

  • National Cancer Institute

    Cairo, 11796

  • Nasser Institute

    Cairo, 12655

Other trials in Egypt

Lebanon3 sites

  • American University of Beirut Medical Center

    Beirut, 11-0236

  • Clinique Dr. Rizk

    Beirut, 1107-2130

  • Rafik Hariri University Hospital

    Beirut, 5244

Other trials in Lebanon

Australia2 sites

  • Mater Medical Centre

    South Brisbane, 4101

  • Princess Alexandria Hospital

    Woolloongabba, 4102

Other trials in Australia

Chile1 site

  • Hospital Clinico San Borja Arriaran

    Santiago, 8320000

Other trials in Chile

Poland1 site

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw, 02097

Other trials in Poland

South Africa1 site

  • Private Practice

    Lyttleton, Gauteng, 0157

Other trials in South Africa

About this study

Official title: 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

The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Read the detailed description

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.

Being tested
isavuconazole
Keywords
invasive fungal infections caused by rare molds, rare yeasts, BAL8557, Isavuconazole, Aspergillosis, or by dimorphic fungi, ASP9766
Medical subject headings
Aspergillosis, Invasive Fungal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isavuconazoleDrug

    Also called BAL8557, ASP9766

    Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral

Study groups in NCT00634049
Study groupRoleWhat they receive
IsavuconazoleExperimentalAdministration of isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days followed by daily administration of isavuconazole (IV) or oral
Receives: Drug: isavuconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT).

    The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, 84 and End of Treatment (EOT [Day 180])

Secondary outcomes (8)

  1. Crude Success Rate of Clinical Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT

    The DRC evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings and Partial resolution of attributable clinical symptoms and physical findings]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, 84 and End of Treatment (EOT [Day 180])

  2. Crude Success Rate of Mycological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT

    The DRC evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication and Presumed eradication]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, 84 and End of Treatment (EOT [Day 180])

  3. Crude Success Rate of Radiological Response to Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and EOT

    The DRC evaluated radiological response to treatment at at day 42, day 84 and EOT. Radiological response outcomes were described as Success [Improvement of at least 25% from baseline for invasive aspergillosis and other filamentous mold infections], [Improvement of at least 50% from baseline for invasive aspergillosis and other filamentous mold infections]; and [Improvement of at least 25% from baseline if EOT occurs prior to day 42 and at least 50% improvement from baseline if EOT occurs after day 42 for invasive aspergillosis and other filamentous mold infections]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, 84 and End of Treatment (EOT [Day 180])

  4. Crude Success Rate of Clinical Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT

    The Investigator evaluated clinical response to treatment at day 42, day 84 and EOT. Clinical response outcomes were described as Success [Resolution of all attributable clinical symptoms and physical findings] and [Resolution of some attributable clinical symptoms and physical findings]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, Day 84 and End of Treatment (EOT [Day 180])

  5. Crude Success Rate of Mycological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT

    The Investigator evaluated mycological response to treatment at day 42, day 84 and EOT. Mycological response outcomes were described as Success [Eradication,Presumed eradication]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, Day 84 and End of Treatment (EOT [Day 180])

  6. Crude Success Rate of Radiological Response to Treatment Evaluated by the Investigator at Day 42, Day 84 and EOT

    The Investigator evaluated radiological response to treatment at day 42, day 84 and EOT. Radiological response outcomes were described as Success [≥ 90% improvement,≥ 50% to < 90% improvement and ≥ 25% to < 50% improvement (for day 42 and EOT, if EOT occurs prior to day 42)]. End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Day 42, Day 84 and End of Treatment (EOT [Day 180])

  7. All-cause Mortality Through Day 42 and Day 84

    All-cause Mortality was assessed through Day 42 and Day 84 and summarized for ITT population End of treatment (EOT) is the last day of study drug administration, with an estimated duration up to 180 days.

    Measured: Baseline to End of Treatment (EOT [Day 180])

  8. Safety - Overall Number of TEAEs

    A Treatment Emergent Adverse Events (TEAE) is any adverse event that starts after the first administration of study drug until 28 days after the last dose of study drug.

    Measured: From the first study drug administration until 28 days after the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2008 (estimated)
  2. Study start22 Apr 2008
  3. Primary completion3 Jan 2014
  4. Study completion5 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00634049
Sponsor's protocol ID
9766-CL-0103
Other IDs
WSA-CS-003, 2006-005003-33
Acronym
VITAL
Status last verified
Nov 2024
First submitted
5 Mar 2008
Last updated
11 Dec 2024
Data monitoring committee
Yes
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Hamed K, Engelhardt M, Kovanda LL, Huang JJ, Yan J, Aram JA. Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies. Sci Rep. 2023 Apr 25;13(1):6730. doi: 10.1038/s41598-023-31788-1.

    PubMed 37185921

  • Kovanda LL, Desai AV, Lu Q, Townsend RW, Akhtar S, Bonate P, Hope WW. Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study). Antimicrob Agents Chemother. 2016 Jul 22;60(8):4568-76. doi: 10.1128/AAC.00514-16. Print 2016 Aug.

    PubMed 27185799

  • Thompson GR 3rd, Rendon A, Ribeiro Dos Santos R, Queiroz-Telles F, Ostrosky-Zeichner L, Azie N, Maher R, Lee M, Kovanda L, Engelhardt M, Vazquez JA, Cornely OA, Perfect JR. Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses. Clin Infect Dis. 2016 Aug 1;63(3):356-62. doi: 10.1093/cid/ciw305. Epub 2016 May 11.

    PubMed 27169478

  • Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, Perfect JR, Thompson GR 3rd, Alangaden GJ, Brown JM, Fredricks DN, Heinz WJ, Herbrecht R, Klimko N, Klyasova G, Maertens JA, Melinkeri SR, Oren I, Pappas PG, Racil Z, Rahav G, Santos R, Schwartz S, Vehreschild JJ, Young JH, Chetchotisakd P, Jaruratanasirikul S, Kanj SS, Engelhardt M, Kaufhold A, Ito M, Lee M, Sasse C, Maher RM, Zeiher B, Vehreschild MJGT; VITAL and FungiScope Mucormycosis Investigators. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016 Jul;16(7):828-837. doi: 10.1016/S1473-3099(16)00071-2. Epub 2016 Mar 9.

    PubMed 26969258

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing isavuconazole in people with Aspergillosis and Invasive Fungal Infections, run by Astellas Pharma Inc at 96 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States, India, Brazil, France, Argentina and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Crude Success Rate of Overall Outcome of Treatment Evaluated by the Data Review Committee (DRC) at Day 42, 84 and End of Treatment (EOT). (time frame: Day 42, 84 and End of Treatment (EOT [Day 180])). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00634049, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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