Trial · NCT01176058
A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis
NCT01176058, Phase 3, Terminated, Pfizer; results first posted 2015-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis. Trials, record NCT01176058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01176058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis
- NCT number
- NCT01176058
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 17 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Candidemia
- Interventions
- Anidulafungin/Fluconazole
- First posted
- 2010-08-05
- Last updated
- 2015-10-28
- Results first posted
- 2015-09-21
- Limitations and caveats
- Due to small enrollment, the per-protocol population was not determined, and analysis was performed on the mITT population.
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 Global Response at End of Intravenous Treatment (EOIT) | End of Intravenous Treatment (Up to Day 42) | Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available \[N/A\] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success. |
| Secondary | Percentage of Participants With Global Response at End of Treatment (EOT) | End of Treatment (Up to Day 42) | Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success. |
| Secondary | Percentage of Participants With Clinical Response at EOIT | End of Intravenous Treatment (Up to Day 42) | Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made. |
| Secondary | Percentage of Participants With Clinical Response at EOT | End of Treatment (Up to Day 42) | Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made. |
| Secondary | Percentage of Participants With Clinical Response at Follow-Up | Post treatment follow-up visit (Up to Day 52) | Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made. |
| Secondary | Percentage of Participants With Microbiological Response at EOIT | End of Intravenous Treatment (Up to Day 42) | Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia). |
| Secondary | Percentage of Participants With Microbiological Response at EOT | End of Treatment (Up to Day 42) | Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia). |
| Secondary | Percentage of Participants With Microbiological Response at Follow-Up | Post treatment follow-up visit (Up to Day 52) | Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia). |
| Secondary | Number of Participants Who Died | Baseline to Day 52 |
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 Global Response at End of Intravenous Treatment (EOIT) | End of Intravenous Treatment (Up to Day 42) | Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Global Response at End of Treatment (EOT) | End of Treatment (Up to Day 42) | MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at EOIT | End of Intravenous Treatment (Up to Day 42) | MITT population. N=number of participants with evaluable data; participants with missing data set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at EOT | End of Treatment (Up to Day 42) | MITT population. N=number of participants with evaluable data; participants with missing data set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Follow-Up | Post treatment follow-up visit (Up to Day 52) | MITT population. N=number of participants with evaluable data; participants with missing data set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response at EOIT | End of Intravenous Treatment (Up to Day 42) | MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response at EOT | End of Treatment (Up to Day 42) | MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Response at Follow-Up | Post treatment follow-up visit (Up to Day 52) | MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Died | Baseline to Day 52 | Safety population: All participants who have received at least one dose of study medication. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group34
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 Global Response at End of Intravenous Treatment (EOIT) | Anidulafungin | Success | 62.50 | 95% Confidence Interval 29.0 to 96.0 | percentage of participants |
| Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) | Fluconazole | Success | 71.43 | 95% Confidence Interval 38.0 to 100.0 | percentage of participants |
| Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) | Anidulafungin | Failure | 37.50 | 95% Confidence Interval 4.0 to 71.0 | percentage of participants |
| Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) | Fluconazole | Failure | 28.57 | 95% Confidence Interval 0.0 to 62.0 | percentage of participants |
| Percentage of Participants With Global Response at End of Treatment (EOT) | Anidulafungin | Success | 62.50 | 95% Confidence Interval 29.0 to 96.0 | percentage of participants |
| Percentage of Participants With Global Response at End of Treatment (EOT) | Fluconazole | Success | 42.86 | 95% Confidence Interval 6.2 to 79.5 | percentage of participants |
| Percentage of Participants With Global Response at End of Treatment (EOT) | Anidulafungin | Failure | 37.50 | 95% Confidence Interval 4.0 to 71.0 | percentage of participants |
| Percentage of Participants With Global Response at End of Treatment (EOT) | Fluconazole | Failure | 57.14 | 95% Confidence Interval 20.5 to 93.8 | percentage of participants |
| Percentage of Participants With Clinical Response at EOIT | Anidulafungin | Success | 75.00 | 95% Confidence Interval 45.0 to 100.0 | percentage of participants |
| Percentage of Participants With Clinical Response at EOIT | Fluconazole | Success | 71.43 | 95% Confidence Interval 38.0 to 100.0 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 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 | 9 | |
| Overall Study | STARTED | Fluconazole | 8 | |
| Overall Study | COMPLETED | Anidulafungin | 5 | |
| Overall Study | COMPLETED | Fluconazole | 5 | |
| Overall Study | NOT COMPLETED | Anidulafungin | 4 | |
| Overall Study | NOT COMPLETED | Fluconazole | 3 |
Source ClinicalTrials.gov
Adverse events52
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 | Supraventricular tachycardia | Cardiac disorders | Anidulafungin | 1 | 9 | |
| other | Supraventricular tachycardia | Cardiac disorders | Fluconazole | 0 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Anidulafungin | 0 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Fluconazole | 2 | 8 | |
| other | Intestinal obsturction | Gastrointestinal disorders | Anidulafungin | 1 | 9 | |
| other | Intestinal obsturction | Gastrointestinal disorders | Fluconazole | 0 | 8 | |
| other | Nausea | Gastrointestinal disorders | Anidulafungin | 0 | 9 | |
| other | Nausea | Gastrointestinal disorders | Fluconazole | 1 | 8 | |
| other | Vomiting | Gastrointestinal disorders | Anidulafungin | 1 | 9 | |
| other | Vomiting | Gastrointestinal disorders | Fluconazole | 2 | 8 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 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 | Fluconazole | ||
| Total, other adverse events | Anidulafungin | 6 | 9 |
| Total, other adverse events | Fluconazole | 6 | 8 |
| Total, serious adverse events | Anidulafungin | 2 | 9 |
| Total, serious adverse events | Fluconazole | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Anidulafungin vs Fluconazole: Number of Participants Who Died | Trial comparisons |
| Anidulafungin vs Fluconazole: 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/NCT01176058
GET https://conductscience.org/api/trials/v1/NCT01176058/results?page=2