Trial · NCT00537329
Anidulafungin In Treatment Of Candidemia In Asian Subjects
NCT00537329, Phase 3, Completed, Pfizer; results first posted 2010-02-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Anidulafungin In Treatment Of Candidemia In Asian Subjects. Trials, record NCT00537329. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00537329
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anidulafungin In Treatment Of Candidemia In Asian Subjects
- NCT number
- NCT00537329
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 43 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Candidemia
- Interventions
- Anidulafungin
- First posted
- 2007-10-01
- Last updated
- 2010-03-09
- Results first posted
- 2010-02-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Global Response of Success at End of Treatment | End of treatment (EOT) = Day 5 up to Day 42 | Number of subjects with clinician assessed global response of success; defined as cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms of Candida infection) on the clinical response in conjunction with eradication (follow up negative culture result for Candida species \[spp\]) or presumed eradication (follow up culture was not available and clinical outcome defined as success) on the microbiological response. |
| Secondary | Number of Subjects With Global Response of Success at Endpoints | End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline) | Number of subjects with clinician assessed global response of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response in conjunction with eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed erad=follow up culture was not available and clinical outcome defined as success on the microbiological response. |
| Secondary | Number of Subjects With Clinical Response of Success at Endpoints | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline | Number of subjects with clinician assessed clinical response (CR) of success. Defined as cure or improvement (cure/improvement): cure=resolution of signs and symptoms of Candida infection; improvement=significant but incomplete resolution of signs and symptoms of Candida infection on the clinical response. |
| Secondary | Number of Subjects With Microbiological Response of Success at Endpoints | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline | Number of subjects with clinician assessed microbiological response (MR) of success. Defined as eradication or presumed eradication (erad/presumed erad): erad=follow up negative culture result for Candida spp; presumed eradication=follow up culture was not available and clinical outcome defined as success on the microbiological response. |
| Secondary | Time to Death From Any Cause | Baseline through end of 12 weeks after baseline | Time to death (median survival time in days) from any cause; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). |
| Secondary | Time to Death Due to Candidemia | Baseline through end of 12 weeks after baseline | Time to death (median survival time in days) due to candidemia; time to death includes the first day (Day 1) of study drug (baseline and Day 1 allowed to occur on same day). EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe "at end of 12 weeks after baseline" could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). |
| Secondary | Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | Absolute values for β-D-glucan (range 0 to 6000 picograms per milliliter \[pg/mL\]) summarized at all timeframe endpoints by subject's at end of all treatment clinical response status of success (Success at EOT) or failure (Failure at EOT) and as combined status of all subjects (All at EOT). Success: cure (resolution of signs and symptoms of Candida infection) or improvement (significant but incomplete resolution of signs and symptoms); failure: no significant improvement in signs and symptoms or death due to Candida infection; subjects must have received at least 3 doses of anidulafungin. |
| Secondary | Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | Change from baseline for β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints by subject's at end of all treatment clinical response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=cure (resolution of signs, symptoms of Candida infection) or improvement (significant but incomplete resolution of signs, symptoms); failure=no significant improvement or death due to Candida infection; subject must have received at least 3 doses of anidulafungin. Percent change calculated as (\[mean value of β-D-glucan at observation-baseline value\]/baseline value\*100). |
| Secondary | Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | Absolute values for β-D-glucan (range 0 to 6000 pg/mL) summarized at timeframe endpoints by subject's at end of all treatment microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success: eradication (follow up negative culture for Candida spp) or presumed eradication (follow up culture was not available and clinical outcome defined as success); failure: persistence (follow up culture was positive for at least 1 baseline Candida spp) or presumed persistence (follow up culture was not available and clinical outcome was defined as failure). |
| Secondary | Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | Change from baseline in β-D-glucan (range 0 to 6000 pg/mL) summarized at endpoints and by subject's EOT microbiological response status of Success at EOT or Failure at EOT and as combined status of All at EOT. Success=eradication (negative culture Candida spp or presumed eradication (culture not available, clinical outcome defined as success); failure=persistence (culture positive for at least 1 baseline Candida spp) or presumed persistence (culture not available, clinical outcome defined as failure). Percent change=(\[mean value of β-D-glucan at observation-baseline value\]/baseline value\*100). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Global Response of Success at End of Treatment | End of treatment (EOT) = Day 5 up to Day 42 | Modified Intent to Treat (MITT): includes all Full Analysis Set (FAS) subjects (received at least 1 dose of study treatment) with confirmed, documented diagnosis of candidemia and had received the initial loading dose of study treatment. | participants | NUMBER |
| SECONDARY | Number of Subjects With Global Response of Success at Endpoints | End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline) | MITT; EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | participants | NUMBER |
| SECONDARY | Number of Subjects With Clinical Response of Success at Endpoints | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline | MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | participants | NUMBER |
| SECONDARY | Number of Subjects With Microbiological Response of Success at Endpoints | EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline | MITT. EOT visit could occur anytime from Day 5 through Day 42; if a subject terminated early, the timeframe at end of 12 weeks after baseline could occur in the follow-up period (6 Wks post EOT or Week 12 post EOT). | participants | NUMBER |
| SECONDARY | Time to Death From Any Cause | Baseline through end of 12 weeks after baseline | MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; \< 50% of subjects died out of the analyzable population. | days | MEDIAN |
| SECONDARY | Time to Death Due to Candidemia | Baseline through end of 12 weeks after baseline | MITT; time to death (median survival time in days) based on Kaplan-Meier method if estimable. Data not summarized by median survival time as planned as median time is not estimable; no subjects died due to candidemia out of the analyzable population. | days | MEDIAN |
| SECONDARY | Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT. | pg/mL | MEAN |
| SECONDARY | Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing or indeterminate CR treated as failures. Failures were carried forward for subjects who withdrew prematurely from study with a documented failure. All category includes all subjects with success or failure at EOT. | percent change | MEAN |
| SECONDARY | Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT. | pg/mL | MEAN |
| SECONDARY | Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT | Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42) | MITT; (n)=number of subjects with analyzable data at observation; summary includes only subjects who completed visit; missing microbiological responses treated as failures. Failures carried forward for subjects who withdrew prematurely from study with documented failure. All category includes all subjects with success or failure at EOT. | percent change | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Global Response of Success at End of Treatment | Anidulafungin | 31 | participants | ||
| Number of Subjects With Global Response of Success at Endpoints | Anidulafungin | EOIT | 33 | participants | |
| Number of Subjects With Global Response of Success at Endpoints | Anidulafungin | 2 Wks post EOT | 24 | participants | |
| Number of Subjects With Global Response of Success at Endpoints | Anidulafungin | 6 Wks post EOT | 17 | participants | |
| Number of Subjects With Global Response of Success at Endpoints | Anidulafungin | 12 Wks post baseline | 16 | participants | |
| Number of Subjects With Clinical Response of Success at Endpoints | Anidulafungin | EOIT: success (cure/improvement) | 34 | participants | |
| Number of Subjects With Clinical Response of Success at Endpoints | Anidulafungin | EOIT: cure | 27 | participants | |
| Number of Subjects With Clinical Response of Success at Endpoints | Anidulafungin | EOIT: improvement | 7 | participants | |
| Number of Subjects With Clinical Response of Success at Endpoints | Anidulafungin | EOT: success (cure/improvement) | 32 | participants | |
| Number of Subjects With Clinical Response of Success at Endpoints | Anidulafungin | EOT: cure | 27 | participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anidulafungin | 43 | |
| Overall Study | COMPLETED | Anidulafungin | 17 | |
| Overall Study | NOT COMPLETED | Anidulafungin | 26 |
Source ClinicalTrials.gov
Adverse events107
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 | Leukopenia | Blood and lymphatic system disorders | Anidulafungin | 2 | 43 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anidulafungin | 1 | 43 | |
| other | Acute coronary syndrome | Cardiac disorders | Anidulafungin | 1 | 43 | |
| other | Cardiac failure congestive | Cardiac disorders | Anidulafungin | 1 | 43 | |
| other | Tachycardia | Cardiac disorders | Anidulafungin | 2 | 43 | |
| other | Asthenopia | Eye disorders | Anidulafungin | 1 | 43 | |
| other | Conjunctivitis | Eye disorders | Anidulafungin | 1 | 43 | |
| other | Abdominal pain | Gastrointestinal disorders | Anidulafungin | 2 | 43 | |
| other | Ascites | Gastrointestinal disorders | Anidulafungin | 1 | 43 | |
| other | Constipation | Gastrointestinal disorders | Anidulafungin | 3 | 43 |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 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 | 30 | 43 |
| Total, serious adverse events | Anidulafungin | 16 | 43 |
Source ClinicalTrials.gov
Papers5
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.
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