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CompletedNCT00413218Updated Dec 10, 2024Results posted

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

A Phase 3 interventional study of Isavuconazole and Caspofungin in Candidiasis, Invasive, Candidemia and Mycoses, sponsored by Astellas Pharma Inc. Completed at 113 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.

Primary conditionCandidemiaRegistry: Candidiasis, InvasiveReclassifiedWhy we changed it
Registry
Candidiasis, Invasive — the first condition term the registry derived for this study.
ClinicalTrials.gg
Candidemia
Why
  1. The study's listed conditions name Candidemia, a narrower term within Candidiasis, Invasive.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Candidiasis, Invasive
  • Candidemia
  • Mycoses

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Keywords

  • Invasive Candida infections
  • BAL8557
  • ASP9766
  • Isavuconazole
  • Candidemia
  • Candidemia and other invasive candida infections
  • Phase III study
03

In context

Candidemia Reclassified

73 studies on the registry are indexed under Candidemia; 5 are open to participants now.

This study's enrollment of 450 is above the median of 63 across 44 interventional studies indexed under Candidemia.

Browse Candidemia studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.

Browse Astellas Pharma Inc studies →

Compared within Candidemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Candidiasis, Invasive. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Isavuconazole (ISA)

    Participants 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.

    Drug: Isavuconazole

  • Active comparator
    Caspofungin (CAS)/Voriconazole

    Participants 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.

    Drug: Caspofungin · Drug: Voriconazole

Interventions

  • DrugIsavuconazole

    Administered by intravenous infusion.

    Also known as: ASP9766, BAL8557

  • DrugCaspofungin

    Administered by intravenous infusion.

    Also known as: Cancidas

  • DrugVoriconazole

    Administered by intravenous infusion.

    Also known as: VFend

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

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

07

Results

Posted Aug 1, 2017
Limitations and caveats
Enrollment in the clinical study was suspended in January 2009 pending further characterization of newly identified impurities. After successful completion of the studies, regulatory notifications and transfer of sponsorship from Basilea to Astellas,

Participant flow

Consenting male and female participants ≥ 18 with candidemia or an invasive Candida infection who had a positive blood or tissue culture obtained within 96 hours prior to randomization and meeting the inclusion/exclusion criteria were enrolled in the study.

Participant flow — Overall Study
MilestoneIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Started223227
Intent to treat population (itt)221219
Completed120131
Not completed10396
Withdrew: Randomized but didn't receive study drug28
Withdrew: Death5756
Withdrew: Lost to follow-up1417
Withdrew: Admin2014
Withdrew: Missing10
Withdrew: Withdrawal by subject91

Outcome measures

PrimaryPercentage 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.

Time frame:
End of Intravenous Treatment (EOIV) (Days 11-56)
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
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 Use60.371.1
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -10.8 · 95% CI -19.9 to -1.8The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryPercentage 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.

Time frame:
End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)
Reported as:
Number · Percentage of Participants
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)
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
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)54.857.2
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -2.7 · 95% CI -12.2 to 6.8The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryPercentage 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).

Time frame:
EOT (Day 56) and FU2 (6 weeks after end of treatment)
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
EOT (Day 56)61.372.1
FU2 (6 weeks after end of treatment)43.248.3
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference %: -10.9 · 95% CI -19.9 to -1.9The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference %: -5.4 · 95% CI -15.00 to 4.2The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryPercentage 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).

Time frame:
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Success- End of Intravenous Treatment (EOIV)76.484.1
Success- End of Treatment (EOT)76.484.6
Success- Follow-up Visit 1 (FU1)67.867.7
Success- Follow-up Visit 2 (FU2)52.858.2
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -8.2 · 95% CI -15.4 to -0.9The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -8.6 · 95% CI -15.8 to -1.5The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -0.4 · 95% CI -9.1 to 8.3The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -5.8 · 95% CI -15.3 to 3.6The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryPercentage 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).

Time frame:
EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Success-EOIV70.985.6
Success-EOT71.987.6
Success-FU166.865.7
Success-FU251.856.7
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -14.9 · 95% CI -22.7 to -7.0The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -15.9 · 95% CI -23.5 to -8.4The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -0.7 · 95% CI -8.1 to 9.6The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -5.2 · 95% CI -14.7 to 4.3The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryPercentage 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).

Time frame:
Day 7 and EOT (Day 56)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Day 761.372.1
EOT72.981.1
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -11.4 · 95% CI -20.4 to -2.5The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -8.5 · 95% CI -16.5 to -0.4The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryPercentage 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.

Time frame:
Day 7 and EOT (Day 56)
Reported as:
Number · Percentage of Participants
Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Day 754.364.7
EOT70.978.6
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -11.1 · 95% CI -20.3 to -1.9The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): -8.1 · 95% CI -16.3 to 0.1The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.
SecondaryAll-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.

Time frame:
Day 14 and Day 56
Reported as:
Number · Percentage of Participants
All-Cause Mortality (ACM) at Day 14 and Day 56
Percentage of ParticipantsIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Day 14 All-cause Mortality14.612.4
Day 56 All-cause Mortality30.729.9
Statistical analysis
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): 2.5 · 95% CI -3.8 to 8.9
  • Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole · Adjusted treatment difference (%): 1.4 · 95% CI -7.1 to 10.0
SecondaryTime 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

Time frame:
Day 1 up to FU1 (2 weeks after EOT (Day 56))
Reported as:
Median · Days
Time to First Confirmed Negative Culture
DaysIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Time to First Confirmed Negative Culture4.0 (3.0 to 6.0)3.0 (3.0 to 4.0)

Adverse events

Collected over Day 1 to FU2 (6 weeks after EOT (Day 56)). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Isavuconazole (ISA)55/220 (25%)112/220 (50.9%)162/220 (73.6%)
Caspofungin (CAS)/Voriconazole55/220 (25%)106/220 (48.2%)167/220 (75.9%)
Most frequent serious events
Showing 10 of 188
Most frequent serious events
EventIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
Septic shockInfections and infestations19/22011/220
SepsisInfections and infestations16/2209/220
Respiratory failureRespiratory, thoracic and mediastinal disorders12/2208/220
Renal failure acuteRenal and urinary disorders10/2203/220
Multi-organ failureGeneral disorders5/2207/220
Cardiac arrestCardiac disorders4/2206/220
PneumoniaInfections and infestations2/2206/220
Respiratory distressRespiratory, thoracic and mediastinal disorders5/2201/220
Bacterial sepsisInfections and infestations3/2204/220
Pulmonary embolismRespiratory, thoracic and mediastinal disorders4/2202/220
Most frequent other events
Showing 10 of 31
Most frequent other events
EventIsavuconazole (ISA)Caspofungin (CAS)/Voriconazole
HypokalaemiaMetabolism and nutrition disorders41/22044/220
DiarrhoeaGastrointestinal disorders33/22041/220
PyrexiaGeneral disorders38/22041/220
VomitingGastrointestinal disorders33/22037/220
ConstipationGastrointestinal disorders32/22024/220
NauseaGastrointestinal disorders21/22030/220
HypomagnesaemiaMetabolism and nutrition disorders18/22029/220
HypotensionVascular disorders22/22027/220
Abdominal painGastrointestinal disorders16/22020/220
AnaemiaBlood and lymphatic system disorders13/22018/220

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Isavuconazole (ISA)Caspofungin (CAS)/VoriconazoleTotal
Geometric mean58.0 ± 17.5457.9 ± 16.8858.0 ± 17.20
Sex: Female, Male
Sex: Female, Male(Participants)Isavuconazole (ISA)Caspofungin (CAS)/VoriconazoleTotal
Female7893171
Male143126269
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Isavuconazole (ISA)Caspofungin (CAS)/VoriconazoleTotal
White150144294
Black or African American11718
Asian5664120
Other448
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Isavuconazole (ISA)Caspofungin (CAS)/VoriconazoleTotal
Hispanic or Latino261945
Not Hispanic or Latino187195382
Missing8513
Neutropenic Status: Presence or Absence of Neutropenia
Neutropenic Status: Presence or Absence of Neutropenia(Participants)Isavuconazole (ISA)Caspofungin (CAS)/VoriconazoleTotal
Presence252449
Absence196195391
Geographical Region
Geographical Region(Participants)Isavuconazole (ISA)Caspofungin (CAS)/VoriconazoleTotal
North America383371
Western Europe5456110
Other Regions129130259
08

Study locations

113 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-0006, United States
  • Somero Research Corporation
    Palm Desert, California 92211, United States
  • University of California Davis Health System
    Sacramento, California 95817, United States
  • University of California at San Francisco
    San Francisco, California 94143, United States
  • Idaho Falls Infectious Diseases PLLC
    Idaho Falls, Idaho 83404, United States
  • Loyola University Hospital
    Maywood, Illinois 60153, United States
  • Springfield Clinic LLP
    Springfield, Illinois 62701, United States
  • Infectious Disease of Indiana
    Indianapolis, Indiana 46280, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • University of Maryland School of Medicine
    Baltimore, Maryland 21201, United States
  • UMASS Memorial Medical Center
    Worcester, Massachusetts 01655, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Mercury Street Medical Group
    Butte, Montana 59701, United States
  • Jersey Shore University Medical Center
    Neptune, New Jersey 07753, United States
  • New York Presbyterian Hospital
    New York, New York 10065, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Regional Infection Diseases Infusion Center Inc.
    Lima, Ohio 45801, United States
  • Temple University Health Sciences
    Philadelphia, Pennsylvania 19140, United States
  • Hospital Britanico de Buenos Aires
    Capital Federal, C1280AEB, Argentina
  • Hospital General de Agudos Dr. Carlos G. Durand
    Capital Federal, C1405DCS, Argentina
  • Hospital Italiano de Buenos Aires
    Ciudad Autonoma, 1181, Argentina
  • Instituto Medico Especializado Alexander Fleming
    Ciudad Autonoma, 1426, Argentina
  • Hospital General de Agudos Dr. Cosme Argerich
    La Boca, 1157, Argentina
  • Fremantle Hospital
    Fremantle, 6160, Australia
  • Mater Adult Hospital
    South Brisbane, Australia
  • Westmead Hospital
    Westmead, Australia
  • Princess Alexandra Hospital
    Woolloongabba, 4102, Australia
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • Universitair Ziekenhuis Brussel
    Brussels, 1090, Belgium
  • ULB Hôpital Erasme
    Bruxelles, 1070, Belgium
  • Universitair Ziekenhuis Gent
    Gent, 9000, Belgium
  • Universitaire Ziekenhuizen Leuven
    Leuven, 3000, Belgium
  • Hospital Felicio Rocho
    Belo Horizonte, 30110-908, Brazil
  • Hospital das Clinicas da Universidade Federal de Minas Gerai
    Belo Horizonte, 30130-100, Brazil
  • Santa Casa de Misericordia de Belo Horizonte
    Belo Horizonte, 30150-221, Brazil
  • Hospital das Clinicas da UFPR
    Curitiba, 80060-150, Brazil
  • Hospital Nossa Senhora das Gracas
    Curitiba, 80810-040, Brazil
  • Hospital Sao Lucas - PUCRS
    Porto Alegre, 90610-000, Brazil
  • Irmandade da Santa Casa de Misericordia de Porto Alegre
    Porto Alegre, Brazil
  • Hospital Universitario Clementino Fraga Filho
    Rio de Janeiro, 21941-913, Brazil
  • Hospital Universitario de Santa Maria
    Santa Maria, 97105-900, Brazil
  • Universidade Federal de Sao Paulo - UNIFESP
    São Paulo, 04020-002, Brazil
  • University of Alberta Hospital
    Edmonton, Alberta T6G 2B7, Canada
  • Hamilton Health Sciences - Henderson Site
    Hamilton, Ontario L8V 1C3, Canada
  • Queen's University
    Kingston, Ontario K7L 3N6, Canada
  • The Ottawa Hospital - General Campus
    Ottawa, Ontario K1H 8L6, Canada
  • University Health Network - Toronto General Hospital
    Toronto, Ontario M5G 2N2, Canada
  • Hôpital Maisonneuve - Rosemont
    Montreal, Quebec H1T 2M4, Canada
  • Hospital Dr. Sotero del Rio
    Puente Alto Santiago, Chile
  • Hospital del Salvador
    Santiago, Chile
  • Hospital Dr. Hernan Henriquez Aravena
    Temuco, 4780000, Chile
  • West China Hospital of Sichuan University
    Chengdu, 610041, China
  • Huashan Hospital Fudan University
    Shanghai, 200040, China
  • Hôpital Hautepierre
    Strasbourg, 67048, France
  • Hôpital de Brabois Adultes
    Vandoeuvre les Nancy, 54511, France
  • Charite Campus Mitte
    Berlin, 10117, Germany
  • Universitaetsklinikum Freiburg
    Freiburg, Germany
  • Universitaet Koeln
    Koeln, 50937, Germany
  • Klinikum St. Georg
    Leipzig, 04129, Germany
  • Universitaetsklinik Leipzig
    Leipzig, 04289, Germany
  • Universitaetsklinikum Leipzig
    Luebeck, Germany
  • Universitaetsklinikum Wuerzburg
    Wuerzburg, 97080, Germany
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
    Debrecen, 4032, Hungary
  • Petz Aladar Megyei Oktato Korhaz
    Györ, 9024, Hungary
  • Max Super Speciality Hospital
    New Delhi, Delhi 110017, India
  • Metro Centre for Respiratory Diseases
    Noida, Delhi 201301, India
  • Kasturba Medical College and Hospital
    Mangalore, Karna 575001, India
  • Kasturba Medical College K. M. C. Hospital
    Manipal, Karna 576104, India
  • Amrita Institute Of Medical Science
    Cochin, Kerala 682041, India
  • Deenanath Mangeshkar Hospital and Research Centre
    Pune, Mahara 411004, India
  • Apollo Hospitals Educational & Research Foundation
    Chennai, India
  • Nizam's Institute of Medical Sciences
    Hyderabad, 500082, India
  • AMRI Hospital
    Kolkata, 700098, India
  • Christian Medical College & Hospital
    Vellore Tamilnadu, India
  • Ha Emek Medical Center
    Afula, 18101, Israel
  • Rambam Health Care Campus
    Haifa, 31096, Israel
  • Wolfson Medical Center
    Holon, 58100, Israel
  • Hadassah Universtiy Hospital - Ein Kerem
    Jerusalem, 91200, Israel
  • Sapir Medical Center, Meir Hospital
    Kfar-Saba, 44281, Israel
  • Rabin MC
    Petah, 49100, Israel
  • Chaim Sheba Medical Center
    Ramat Gan, 52621, Israel
  • Sourasky MC Ichilov Hospital Tel Aviv
    Tel Aviv, 64239, Israel
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Ma
    Bologna, 40138, Italy
  • Azienda Ospedaliera Spedali Civili di Brescia
    Brescia, 25126, Italy
  • Ente Ospedaliero Ospedeli Galliera
    Genova, 16128, Italy
  • Azienda Ospedaliero Universitaria San Martino
    Genova, 16132, Italy
  • Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
    Verona, 37134, Italy
  • AUB Medical Center
    Beirut, 11-0236, Lebanon
  • Rafik Hariri Uni Hospital
    Beirut, 5244, Lebanon
  • Hospital Ampang
    Ampang, 68000, Malaysia
  • Pusat Perubatan Universiti Kebangsaan Malaysia
    Kuala Lumpur, 56000, Malaysia
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
    Guadalajara, 44280, Mexico
  • Hospital Civil de Guadalajara Dr Juan I Menchaca
    Guadalajara, 44340, Mexico
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador
    Mexico, 14000, Mexico
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
    Monterrey, 64460, Mexico
  • Auckland City Hospital
    Auckland, New Zealand
  • Waikato Urology Research Ltd
    Hamilton, New Zealand
  • De La Salle Health Sciences Institute- DLSUMC
    Cavite City, Philippines
  • Philippine General Hospital
    Manila, Philippines
  • S.I. Russian Oncological Research Center n.a. N.N. Blokhin
    Moscow, 115478, Russian Federation

Showing the first 100 of 113 sites across 25 countries. Choose a country and city above to see the rest.

09

References and documents

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 ↗

Individual participant data

Plan to share: 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/.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

Access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Data sharing details ↗ · www.clinicaltrials.astellas.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00413218
Lead sponsor
Astellas Pharma Inc
Collaborators
Basilea Pharmaceutica
Responsible party
Sponsor
First posted
Dec 19, 2006
Start date
Mar 8, 2007
Primary completion
Mar 3, 2015
Completion
Mar 3, 2015
Results posted
Aug 1, 2017
Last update
Dec 10, 2024

Study contacts

Medical Director
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Isavuconazole

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