Trial · NCT01202253
Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
NCT01202253, Completed, Pfizer; results first posted 2012-10-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom. Trials, record NCT01202253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01202253
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
- NCT number
- NCT01202253
- Status
- Completed
- Enrollment
- 50 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Candidiasis
- Interventions
- anidulafungin
- First posted
- 2010-09-15
- Last updated
- 2014-04-16
- Results first posted
- 2012-10-11
- Limitations and caveats
Protocol-specified endpoint, percentage of participants with presumed eradication of infecting species, was not presented as a separate outcome measure because the 'presumed eradication' was considered same as favorable clinical response.
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Favorable Outcome | Day 28 post-treatment | Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. |
| Secondary | Percentage of Participants With Unfavorable Outcome | Day 28 post-treatment | Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy. |
| Secondary | Percentage of Participants Who Died Due to All Causes | Baseline up to Day 28 post-treatment | Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes. |
| Secondary | Percentage of Participants With Death Attributable to Fungal Infection | Baseline up to Day 28 post-treatment | |
| Secondary | Percentage of Participants With Death Unrelated to Fungal Infection | Baseline up to Day 28 post-treatment | |
| Secondary | Percentage of Participants With Favorable Clinical Response | Day 28 post-treatment | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. |
| Secondary | Percentage of Participants With Lack of Clinical Response | Day 28 post-treatment | Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy. |
| Secondary | Percentage of Participants Requiring Change or Additional Antifungal Therapy | Baseline up to Day 28 post-treatment | Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100). |
| Secondary | Percentage of Participants With Oral Antifungal Started to Complete Therapy | Baseline up to Day 28 post-treatment | |
| Secondary | Percentage of Participants With Documented Eradication of Infecting Species | Baseline | Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
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 Favorable Outcome | Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Unfavorable Outcome | Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died Due to All Causes | Baseline up to Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Death Attributable to Fungal Infection | Baseline up to Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Death Unrelated to Fungal Infection | Baseline up to Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Clinical Response | Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Lack of Clinical Response | Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring Change or Additional Antifungal Therapy | Baseline up to Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Oral Antifungal Started to Complete Therapy | Baseline up to Day 28 post-treatment | Full analysis set included all participants who met the defined eligibility criteria. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Documented Eradication of Infecting Species | Baseline | Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants' medical notes. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group106
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 Favorable Outcome | Anidulafungin | 76.1 | 95% Confidence Interval 64.3 to 87.9 | percentage of participants | |
| Percentage of Participants With Unfavorable Outcome | Anidulafungin | 23.9 | 95% Confidence Interval 12.1 to 35.7 | percentage of participants | |
| Percentage of Participants Who Died Due to All Causes | Anidulafungin | 38.0 | 95% Confidence Interval 24.5 to 51.5 | percentage of participants | |
| Percentage of Participants With Death Attributable to Fungal Infection | Anidulafungin | 0 | 0 to 0 | percentage of participants | |
| Percentage of Participants With Death Unrelated to Fungal Infection | Anidulafungin | 36.0 | 95% Confidence Interval 22.7 to 49.3 | percentage of participants | |
| Percentage of Participants With Favorable Clinical Response | Anidulafungin | 80.4 | 95% Confidence Interval 69.4 to 91.4 | percentage of participants | |
| Percentage of Participants With Lack of Clinical Response | Anidulafungin | 19.6 | 95% Confidence Interval 8.6 to 30.6 | percentage of participants | |
| Percentage of Participants Requiring Change or Additional Antifungal Therapy | Anidulafungin | Due to all reasons | 16.0 | 95% Confidence Interval 5.8 to 26.2 | percentage of participants |
| Percentage of Participants Requiring Change or Additional Antifungal Therapy | Anidulafungin | Due to lack of clinical response | 4.0 | 95% Confidence Interval 0.0 to 9.4 | percentage of participants |
| Percentage of Participants Requiring Change or Additional Antifungal Therapy | Anidulafungin | Due to adverse event | 0.0 | 95% Confidence Interval 0.0 to 0.0 | percentage of participants |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 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 | 50 | |
| Overall Study | COMPLETED | Anidulafungin | 50 | |
| Overall Study | NOT COMPLETED | Anidulafungin | 0 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | New Candida parapsilosis infection | General disorders | Anidulafungin | 1 | 50 | |
| serious | Breakthrough Candida glabrata infection | General disorders | Anidulafungin | 2 | 50 | |
| serious | Breakthrough Candida parapsilosis infection | General disorders | Anidulafungin | 1 | 50 | |
| serious | Continuing Candida glabrata infection | General disorders | Anidulafungin | 1 | 50 |
Source ClinicalTrials.gov
Adverse 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 | 0 | 50 |
| Total, serious adverse events | Anidulafungin | 5 | 50 |
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 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/NCT01202253
GET https://conductscience.org/api/trials/v1/NCT01202253/registered?page=2