Trial · NCT00413218
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
NCT00413218, Phase 3, Completed, Astellas Pharma Inc; results first posted 2017-08-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections. Trials, record NCT00413218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
- NCT number
- NCT00413218
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 450 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Candidiasis, Invasive, Candidemia, Mycoses
- Interventions
- Isavuconazole, Caspofungin, Voriconazole
- First posted
- 2006-12-19
- Last updated
- 2024-12-10
- Other registries' IDs
- eudract:2006-003951-18
- Results first posted
- 2017-08-01
- 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,
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | End of Intravenous Treatment (EOIV) (Days 11-56) | 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. |
| Secondary | 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) | End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment) | 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. |
| Secondary | 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 | EOT (Day 56) and FU2 (6 weeks after end of treatment) | 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). |
| Secondary | Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC) | EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment) | 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). |
| Secondary | Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC) | EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment) | 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). |
| Secondary | Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator | Day 7 and EOT (Day 56) | Success was defined as mycological response (eradication or presumed eradication). |
| Secondary | Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator | Day 7 and EOT (Day 56) | Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms. |
| Secondary | All-Cause Mortality (ACM) at Day 14 and Day 56 | 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. |
| Secondary | Time to First Confirmed Negative Culture | Day 1 up to FU1 (2 weeks after EOT (Day 56)) | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | End of Intravenous Treatment (EOIV) (Days 11-56) | The ITT population consisted of all randomized participants who received at least one dose of study drug. The mITT population consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. Reporting arms included participants who switched to oral ISA and CAS. | Percentage of Participants | NUMBER |
| SECONDARY | 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) | End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole. | Percentage of Participants | NUMBER |
| SECONDARY | 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 | EOT (Day 56) and FU2 (6 weeks after end of treatment) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC) | EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC) | EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator | Day 7 and EOT (Day 56) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator | Day 7 and EOT (Day 56) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole | Percentage of Participants | NUMBER |
| SECONDARY | All-Cause Mortality (ACM) at Day 14 and Day 56 | Day 14 and Day 56 | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Confirmed Negative Culture | Day 1 up to FU1 (2 weeks after EOT (Day 56)) | The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Isavuconazole (ISA) | 60.3 | 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 | Caspofungin (CAS)/Voriconazole | 71.1 | 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) | Isavuconazole (ISA) | 54.8 | 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) | Caspofungin (CAS)/Voriconazole | 57.2 | 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 | Isavuconazole (ISA) | EOT (Day 56) | 61.3 | 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 | Caspofungin (CAS)/Voriconazole | EOT (Day 56) | 72.1 | 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 | Isavuconazole (ISA) | FU2 (6 weeks after end of treatment) | 43.2 | 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 | Caspofungin (CAS)/Voriconazole | FU2 (6 weeks after end of treatment) | 48.3 | 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) | Isavuconazole (ISA) | Success- End of Intravenous Treatment (EOIV) | 76.4 | 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) | Caspofungin (CAS)/Voriconazole | Success- End of Intravenous Treatment (EOIV) | 84.1 | Percentage of Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Isavuconazole (ISA) | 223 | |
| Overall Study | STARTED | Caspofungin (CAS)/Voriconazole | 227 | |
| Overall Study | Intent to Treat Population (ITT) | Isavuconazole (ISA) | 221 | |
| Overall Study | Intent to Treat Population (ITT) | Caspofungin (CAS)/Voriconazole | 219 | |
| Overall Study | COMPLETED | Isavuconazole (ISA) | 120 | |
| Overall Study | COMPLETED | Caspofungin (CAS)/Voriconazole | 131 | |
| Overall Study | NOT COMPLETED | Isavuconazole (ISA) | 103 | |
| Overall Study | NOT COMPLETED | Caspofungin (CAS)/Voriconazole | 96 |
Source ClinicalTrials.gov
Adverse events438
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Isavuconazole (ISA) | 13 | 220 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Caspofungin (CAS)/Voriconazole | 18 | 220 | 21 |
| other | Tachycardia | Cardiac disorders | Isavuconazole (ISA) | 18 | 220 | 20 |
| other | Tachycardia | Cardiac disorders | Caspofungin (CAS)/Voriconazole | 9 | 220 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | Isavuconazole (ISA) | 16 | 220 | 17 |
| other | Abdominal pain | Gastrointestinal disorders | Caspofungin (CAS)/Voriconazole | 20 | 220 | 23 |
| other | Constipation | Gastrointestinal disorders | Isavuconazole (ISA) | 32 | 220 | 34 |
| other | Constipation | Gastrointestinal disorders | Caspofungin (CAS)/Voriconazole | 24 | 220 | 31 |
| other | Diarrhoea | Gastrointestinal disorders | Isavuconazole (ISA) | 33 | 220 | 37 |
| other | Diarrhoea | Gastrointestinal disorders | Caspofungin (CAS)/Voriconazole | 41 | 220 | 49 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isavuconazole (ISA) | 55 | 220 |
| Total, all-cause mortality | Caspofungin (CAS)/Voriconazole | 55 | 220 |
| Total, other adverse events | Isavuconazole (ISA) | 162 | 220 |
| Total, other adverse events | Caspofungin (CAS)/Voriconazole | 167 | 220 |
| Total, serious adverse events | Isavuconazole (ISA) | 112 | 220 |
| Total, serious adverse events | Caspofungin (CAS)/Voriconazole | 106 | 220 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole: deaths from any cause | Trial comparisons |
| Isavuconazole (ISA) vs Caspofungin (CAS)/Voriconazole: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00413218
GET https://conductscience.org/api/trials/v1/NCT00413218/results?page=2