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Candidiasis, InvasivePhase 3NCT00413218

Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

A Phase 3 study testing Isavuconazole, Caspofungin and Voriconazole in people with Candidiasis, Invasive and Candidemia, run by Astellas Pharma Inc at 113 sites in 25 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 the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidiasis, Invasive, Candidemia, Mycoses
What is being tested?
Isavuconazole, Caspofungin and Voriconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
113 sitesin 25 countries
Study dates
8 Mar 2007to 3 Mar 2015
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

  • Patients with candidemia or with an invasive Candida infection
  • Presence of fever, hypothermia or other appropriate local sign of infection
  • Female patients must be non-lactating and at no risk of pregnancy

Who cannot join

  • Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens
  • Patients with candidemia who failed a previous antifungal therapy for the same infection
  • Patients previously enrolled in a phase III study with isavuconazole
  • Patients with a body weight <40kg

Trial locations and contacts

113 sites in 25 countries.

113 sites in 25 countries

United States18 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-0006

  • Mercury Street Medical Group

    Butte, Montana, 59701

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Idaho Falls Infectious Diseases PLLC

    Idaho Falls, Idaho, 83404

  • Infectious Disease of Indiana

    Indianapolis, Indiana, 46280

  • Regional Infection Diseases Infusion Center Inc.

    Lima, Ohio, 45801

  • Loyola University Hospital

    Maywood, Illinois, 60153

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital

    New York, New York, 10065

  • Somero Research Corporation

    Palm Desert, California, 92211

  • Temple University Health Sciences

    Philadelphia, Pennsylvania, 19140

  • University of California Davis Health System

    Sacramento, California, 95817

  • University of California at San Francisco

    San Francisco, California, 94143

  • Springfield Clinic LLP

    Springfield, Illinois, 62701

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Brazil10 sites

  • Hospital Felicio Rocho

    Belo Horizonte, 30110-908

  • Hospital das Clinicas da Universidade Federal de Minas Gerai

    Belo Horizonte, 30130-100

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Hospital das Clinicas da UFPR

    Curitiba, 80060-150

  • Hospital Nossa Senhora das Gracas

    Curitiba, 80810-040

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, 90610-000

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre

  • Hospital Universitario Clementino Fraga Filho

    Rio de Janeiro, 21941-913

  • Hospital Universitario de Santa Maria

    Santa Maria, 97105-900

  • Universidade Federal de Sao Paulo - UNIFESP

    São Paulo, 04020-002

Other trials in Brazil

India10 sites

  • Apollo Hospitals Educational & Research Foundation

    Chennai

  • Nizam's Institute of Medical Sciences

    Hyderabad, 500082

  • Amrita Institute Of Medical Science

    Kochi, Kerala, 682041

  • AMRI Hospital

    Kolkata, 700098

  • Kasturba Medical College and Hospital

    Mangalore, Karna, 575001

  • Kasturba Medical College K. M. C. Hospital

    Manipal, Karna, 576104

  • Max Super Speciality Hospital

    New Delhi, National Capital Territory of Delhi, 110017

  • Metro Centre for Respiratory Diseases

    Noida, National Capital Territory of Delhi, 201301

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Mahara, 411004

  • Christian Medical College & Hospital

    Vellore Tamilnadu

Other trials in India

Israel8 sites

  • Ha Emek Medical Center

    Afula, 18101

  • Rambam Health Care Campus

    Haifa, 31096

  • Wolfson Medical Center

    Holon, 58100

  • Hadassah Universtiy Hospital - Ein Kerem

    Jerusalem, 91200

  • Sapir Medical Center, Meir Hospital

    Kfar Saba, 44281

  • Rabin MC

    Petah, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Sourasky MC Ichilov Hospital Tel Aviv

    Tel Aviv, 64239

Other trials in Israel

Germany7 sites

  • Charite Campus Mitte

    Berlin, 10117

  • Universitaet Koeln

    Cologne, 50937

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau

  • Klinikum St. Georg

    Leipzig, 04129

  • Universitaetsklinik Leipzig

    Leipzig, 04289

  • Universitaetsklinikum Leipzig

    Lübeck

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Canada6 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Hamilton Health Sciences - Henderson Site

    Hamilton, Ontario, L8V 1C3

  • Queen's University

    Kingston, Ontario, K7L 3N6

  • Hôpital Maisonneuve - Rosemont

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • University Health Network - Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Thailand6 sites

  • Siriraj Hospital

    Bangkoknoi, 10700

  • 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

Argentina5 sites

  • Hospital Britanico de Buenos Aires

    Capital Federal, C1280AEB

  • Hospital General de Agudos Dr. Carlos G. Durand

    Capital Federal, C1405DCS

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma, 1181

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma, 1426

  • Hospital General de Agudos Dr. Cosme Argerich

    La Boca, 1157

Other trials in Argentina

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • ULB Hôpital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

Other trials in Belgium

Italy5 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma

    Bologna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25126

  • Ente Ospedaliero Ospedeli Galliera

    Genova, 16128

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

    Verona, 37134

Other trials in Italy

Australia4 sites

  • Fremantle Hospital

    Fremantle, 6160

  • Mater Adult Hospital

    South Brisbane

  • Westmead Hospital

    Westmead

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Mexico4 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Hospital Civil de Guadalajara Dr Juan I Menchaca

    Guadalajara, 44340

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador

    México, 14000

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Chile3 sites

  • Hospital Dr. Sotero del Rio

    Puente Alto Santiago

  • Hospital del Salvador

    Santiago

  • Hospital Dr. Hernan Henriquez Aravena

    Temuco, 4780000

Other trials in Chile

China2 sites

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Huashan Hospital Fudan University

    Shanghai, 200040

Other trials in China

France2 sites

  • Hôpital Hautepierre

    Strasbourg, 67048

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Hungary2 sites

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

Other trials in Hungary

Lebanon2 sites

  • AUB Medical Center

    Beirut, 11-0236

  • Rafik Hariri Uni Hospital

    Beirut, 5244

Other trials in Lebanon

Malaysia2 sites

  • Hospital Ampang

    Ampang, 68000

  • Pusat Perubatan Universiti Kebangsaan Malaysia

    Kuala Lumpur, 56000

Other trials in Malaysia

New Zealand2 sites

  • Auckland City Hospital

    Auckland

  • Waikato Urology Research Ltd

    Hamilton

Other trials in New Zealand

Philippines2 sites

  • De La Salle Health Sciences Institute- DLSUMC

    Cavite City

  • Philippine General Hospital

    Manila

Other trials in Philippines

Russia2 sites

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

    Moscow, 115478

  • State Institution "Hematology Research Center" RAMS

    Moscow, 125167

Other trials in Russia

Singapore2 sites

  • Singapore General Hospital - Parent

    Singapore, 169608

  • National Neuroscience Institute

    Singapore, 308433

Other trials in Singapore

Switzerland2 sites

  • Hôpitaux Universitaires de Genève - HUG

    Geneva

  • Universitaetsspital Zuerich

    Zurich

Other trials in Switzerland

South Africa1 site

  • Unitas Hospital

    Lyttelton Centurion, 0157

Other trials in South Africa

Spain1 site

  • Hospital del Mar

    Barcelona, 08003

Other trials in Spain

About this study

Official title: A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Read the detailed description

Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are randomized to isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Being tested
Isavuconazole, Caspofungin, Voriconazole
Keywords
Invasive Candida infections, BAL8557, ASP9766, Isavuconazole, Candidemia, Candidemia and other invasive candida infections, Phase III study
Medical subject headings
Candidiasis, Invasive, Candidemia, Mycoses

What participants receive

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

  • IsavuconazoleDrug

    Also called ASP9766, BAL8557

    Administered by intravenous infusion.

  • CaspofunginDrug

    Also called Cancidas

    Administered by intravenous infusion.

  • VoriconazoleDrug

    Also called VFend

    Administered by intravenous infusion.

Study groups in NCT00413218
Study groupRoleWhat they receive
Isavuconazole (ISA)ExperimentalParticipants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.
Receives: Drug: Isavuconazole
Caspofungin (CAS)/VoriconazoleActive comparatorParticipants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.
Receives: Drug: Caspofungin; Drug: Voriconazole

What is being measured

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

  1. Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use

    A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.

    Measured: End of Intravenous Treatment (EOIV) (Days 11-56)

Secondary outcomes (8)

  1. Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)

    A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.

    Measured: End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)

  2. Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2

    A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).

    Measured: EOT (Day 56) and FU2 (6 weeks after end of treatment)

  3. Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)

    A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).

    Measured: EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)

  4. Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)

    A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).

    Measured: EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)

  5. Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator

    Success was defined as mycological response (eradication or presumed eradication).

    Measured: Day 7 and EOT (Day 56)

  6. Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator

    Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.

    Measured: Day 7 and EOT (Day 56)

  7. All-Cause Mortality (ACM) at Day 14 and Day 56

    All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.

    Measured: Day 14 and Day 56

  8. Time to First Confirmed Negative Culture

    The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis

    Measured: Day 1 up to FU1 (2 weeks after EOT (Day 56))

Timeline

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

  1. First posted19 Dec 2006 (estimated)
  2. Study start8 Mar 2007
  3. Primary completion3 Mar 2015
  4. Study completion3 Mar 2015

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413218
Sponsor's protocol ID
9766-CL-0105
Other IDs
WSA-CS-008, 2006-003951-18
Status last verified
Nov 2024
First submitted
18 Dec 2006
Last updated
10 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

  • Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.

    PubMed 30289478

  • McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.

    PubMed 25902926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Isavuconazole, Caspofungin and Voriconazole in people with Candidiasis, Invasive and Candidemia, run by Astellas Pharma Inc at 113 sites in 25 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 3 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 10 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 113 sites in United States, Brazil, India, Israel, Germany and 20 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 1 Aug 2017). 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?

Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use (time frame: End of Intravenous Treatment (EOIV) (Days 11-56)). 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 NCT00413218, which also lists 2 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 10 Dec 2024.

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