Trial · NCT00806351
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
NCT00806351, Phase 3, Terminated, Pfizer; results first posted 2012-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System. Trials, record NCT00806351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00806351
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
- NCT number
- NCT00806351
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Fungemia, Neutropenia, Candidiasis
- Interventions
- Active Anidulafungin, Active Caspofungin
- First posted
- 2008-12-10
- Last updated
- 2012-12-20
- Results first posted
- 2012-12-20
- Limitations and caveats
Study prematurely terminated due to slow enrollment, not due to safety issues. Meaningful interpretation and comparison of treatment outcomes with caspofungin was difficult due to low number of participants (n=3) with confirmed Candida infection.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Global Response at End of Intravenous Treatment (EOIVT) | Day 10 up to Day 42 | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Secondary | Global Response at End of Treatment (EOT) | Day 14 up to Day 56 | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Secondary | Global Response at 2-Week Follow-Up Visit | 2 weeks post treatment | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Secondary | Global Response at 6-Week Follow-Up Visit | 6 weeks post treatment | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Secondary | Response Based on Clinical Cure and Microbiological Success at EOIVT | Day 10 up to Day 42 | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Secondary | Response Based on Clinical Cure and Microbiological Success at EOT | Day 14 up to Day 56 | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Secondary | Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | 2 weeks post treatment | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Secondary | Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | 6 weeks post treatment | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Secondary | Clinical Response at Day 10 | Day 10 | Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate. |
| Secondary | Number of Participants With Recurrence | 2 and 6 weeks post treatment | Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Global Response at End of Intravenous Treatment (EOIVT) | Day 10 up to Day 42 | Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits. | participants | NUMBER |
| SECONDARY | Global Response at End of Treatment (EOT) | Day 14 up to Day 56 | MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits. | participants | NUMBER |
| SECONDARY | Global Response at 2-Week Follow-Up Visit | 2 weeks post treatment | MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data. | participants | NUMBER |
| SECONDARY | Global Response at 6-Week Follow-Up Visit | 6 weeks post treatment | MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data. | participants | NUMBER |
| SECONDARY | Response Based on Clinical Cure and Microbiological Success at EOIVT | Day 10 up to Day 42 | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits. | participants | NUMBER |
| SECONDARY | Response Based on Clinical Cure and Microbiological Success at EOT | Day 14 up to Day 56 | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits. | participants | NUMBER |
| SECONDARY | Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | 2 weeks post treatment | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point | participants | NUMBER |
| SECONDARY | Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | 6 weeks post treatment | MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point | participants | NUMBER |
| SECONDARY | Clinical Response at Day 10 | Day 10 | MITT Population; Number of participants analyzed (N): participants with evaluable data | participants | NUMBER |
| SECONDARY | Number of Participants With Recurrence | 2 and 6 weeks post treatment | MITT Population | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Global Response at End of Intravenous Treatment (EOIVT) | Anidulafungin | Success | 8 | participants | |
| Global Response at End of Intravenous Treatment (EOIVT) | Caspofungin | Success | 3 | participants | |
| Global Response at End of Intravenous Treatment (EOIVT) | Anidulafungin | Failure | 3 | participants | |
| Global Response at End of Intravenous Treatment (EOIVT) | Caspofungin | Failure | 0 | participants | |
| Global Response at End of Intravenous Treatment (EOIVT) | Anidulafungin | Indeterminate | 0 | participants | |
| Global Response at End of Intravenous Treatment (EOIVT) | Caspofungin | Indeterminate | 0 | participants | |
| Global Response at End of Treatment (EOT) | Anidulafungin | Success | 8 | participants | |
| Global Response at End of Treatment (EOT) | Caspofungin | Success | 3 | participants | |
| Global Response at End of Treatment (EOT) | Anidulafungin | Failure | 3 | participants | |
| Global Response at End of Treatment (EOT) | Caspofungin | Failure | 0 | participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anidulafungin | 15 | |
| Overall Study | STARTED | Caspofungin | 6 | |
| Overall Study | COMPLETED | Anidulafungin | 10 | |
| Overall Study | COMPLETED | Caspofungin | 2 | |
| Overall Study | NOT COMPLETED | Anidulafungin | 5 | |
| Overall Study | NOT COMPLETED | Caspofungin | 4 |
Source ClinicalTrials.gov
Adverse events244
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 | Anidulafungin | 1 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Caspofungin | 1 | 6 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Anidulafungin | 1 | 15 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Caspofungin | 0 | 6 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Anidulafungin | 1 | 15 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Caspofungin | 0 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Anidulafungin | 1 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Caspofungin | 0 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anidulafungin | 1 | 15 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Caspofungin | 0 | 6 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anidulafungin | ||
| Total, all-cause mortality | Caspofungin | ||
| Total, other adverse events | Anidulafungin | 14 | 15 |
| Total, other adverse events | Caspofungin | 5 | 6 |
| Total, serious adverse events | Anidulafungin | 5 | 15 |
| Total, serious adverse events | Caspofungin | 4 | 6 |
Source ClinicalTrials.gov
Papers3
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anidulafungin vs Caspofungin: Response Based on Clinical Cure and Microbiological Success at EOIVT | Trial comparisons |
| Anidulafungin vs Caspofungin: Response Based on Clinical Cure and Microbiological Success at EOT | Trial comparisons |
| Anidulafungin vs Caspofungin: Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | Trial comparisons |
| Anidulafungin vs Caspofungin: Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | Trial comparisons |
| Anidulafungin vs Caspofungin: 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.
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