Trial · NCT00689338
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
NCT00689338, Phase 3, Completed, Pfizer; results first posted 2011-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study. Trials, record NCT00689338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689338
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
- NCT number
- NCT00689338
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Invasive Candidiasis
- Interventions
- Anidulafungin, Fluconazole, Voriconazole
- First posted
- 2008-06-03
- Last updated
- 2011-05-30
- Results first posted
- 2011-05-17
- Limitations and caveats
In a change to the protocol, time to first negative blood/tissue culture will only concern time to first negative blood culture. Lack of regular tissue sampling meant that analysis of time to first tissue culture could not be meaningfully performed.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Global Treatment Response Success at End of Treatment | End of Treatment (Day 14 to Day 56) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). |
| Secondary | Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) | EOIVT (Day 10 up to Day 42) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). |
| Secondary | Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment | 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). |
| Secondary | Percentage of Participants With Global Response Success 6 Weeks After End of Treatment | 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). |
| Secondary | Time to First Negative Blood Culture | Day 1 up to Day 42 | Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication. |
| Secondary | Day 90 Survival | Day 90 | Percentage of participants known or assumed to be alive on Day 90. |
| Secondary | Time to Successful Intensive Care Unit (ICU) Discharge | Day 1 up to Day 56 | Time from start of study medication to successful ICU discharge (by end of treatment \[EOT\]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT. |
Source ClinicalTrials.gov
Outcomes7
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 Treatment Response Success at End of Treatment | End of Treatment (Day 14 to Day 56) | Modified Intent-To-Treat (MITT) analysis set: all participants in the ITT population with confirmed diagnosis of candidemia or invasive candidiasis, documented within 96 hours prior to initiation of study treatment or 48 hours after commencing treatment. N excludes participants with missing or unknown global responses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) | EOIVT (Day 10 up to Day 42) | MITT; N excludes participants with missing or unknown global responses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment | 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) | MITT; N excludes participants with missing or unknown global responses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Global Response Success 6 Weeks After End of Treatment | 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) | MITT; N excludes participants with missing or unknown global responses. | percentage of participants | NUMBER |
| SECONDARY | Time to First Negative Blood Culture | Day 1 up to Day 42 | MITT. N = participants who received a minimum of 3 days of dosing with anidulafungin, excluding participants who experienced invasive candidiasis either at baseline or while on anidulafungin and participants who did not have a first negative blood culture by EOIVT. | days | MEAN |
| SECONDARY | Day 90 Survival | Day 90 | MITT | percentage of participants | NUMBER |
| SECONDARY | Time to Successful Intensive Care Unit (ICU) Discharge | Day 1 up to Day 56 | MITT. N = participants who had a successful ICU discharge. | days | MEAN |
Source ClinicalTrials.gov
Results by group7
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 Treatment Response Success at End of Treatment | Anidulafungin | 69.5 | 95% Confidence Interval 61.6 to 76.6 | percentage of participants | |
| Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) | Anidulafungin | 70.7 | 95% Confidence Interval 62.9 to 77.7 | percentage of participants | |
| Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment | Anidulafungin | 60.2 | 95% Confidence Interval 51.1 to 68.7 | percentage of participants | |
| Percentage of Participants With Global Response Success 6 Weeks After End of Treatment | Anidulafungin | 50.5 | 95% Confidence Interval 40.7 to 60.2 | percentage of participants | |
| Time to First Negative Blood Culture | Anidulafungin | 3.7 | 95% Confidence Interval 3.0 to 4.3 | days | |
| Day 90 Survival | Anidulafungin | 54.1 | 95% Confidence Interval 46.3 to 61.8 | percentage of participants | |
| Time to Successful Intensive Care Unit (ICU) Discharge | Anidulafungin | 16.2 | 95% Confidence Interval 13.3 to 19.1 | days |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anidulafungin | 216 | |
| Overall Study | COMPLETED | Anidulafungin | 73 | |
| Overall Study | NOT COMPLETED | Anidulafungin | 143 |
Source ClinicalTrials.gov
Adverse events100
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 | 16 | 216 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anidulafungin | 11 | 216 | |
| other | Atrial fibrillation | Cardiac disorders | Anidulafungin | 11 | 216 | |
| other | Tachycardia | Cardiac disorders | Anidulafungin | 11 | 216 | |
| other | Diarrhoea | Gastrointestinal disorders | Anidulafungin | 20 | 216 | |
| other | Nausea | Gastrointestinal disorders | Anidulafungin | 12 | 216 | |
| other | Pyrexia | General disorders | Anidulafungin | 12 | 216 | |
| other | Hypertension | Vascular disorders | Anidulafungin | 16 | 216 | |
| other | Hypotension | Vascular disorders | Anidulafungin | 15 | 216 | |
| serious | Anaemia | Blood and lymphatic system disorders | Anidulafungin | 1 | 216 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anidulafungin | ||
| Total, other adverse events | Anidulafungin | 78 | 216 |
| Total, serious adverse events | Anidulafungin | 107 | 216 |
Source ClinicalTrials.gov
Papers4
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00689338
GET https://conductscience.org/api/trials/v1/NCT00689338/events?page=2