A Phase 3 interventional study of Anidulafungin/Fluconazole in Candidemia, sponsored by Pfizer. Terminated at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-28.
Sponsored by Pfizer · Phase 3 and Interventional
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.
To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 17 is below the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Anidulafungin/Fluconazole
Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
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.
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Global Response at End of Treatment (EOT)
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.
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at EOIT
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.
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at EOT
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.
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at Follow-Up
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.
Time frame: Post treatment follow-up visit (Up to Day 52)
Percentage of Participants With Microbiological Response at EOIT
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).
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Microbiological Response at EOT
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).
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Microbiological Response at Follow-Up
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).
Time frame: Post treatment follow-up visit (Up to Day 52)
Number of Participants Who Died
Time frame: Baseline to Day 52
| Milestone | Anidulafungin | Fluconazole |
|---|---|---|
| Started | 9 | 8 |
| Completed | 5 | 5 |
| Not completed | 4 | 3 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Insufficient clinical response | 2 | 2 |
| Withdrew: Insufficient mycological response | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 62.50 (29.0 to 96.0) | 71.43 (38.0 to 100.0) |
| Failure | 37.50 (4.0 to 71.0) | 28.57 (0.0 to 62.0) |
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.
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 62.50 (29.0 to 96.0) | 42.86 (6.2 to 79.5) |
| Failure | 37.50 (4.0 to 71.0) | 57.14 (20.5 to 93.8) |
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.
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 75.00 (45.0 to 100.0) | 71.43 (38.0 to 100.0) |
| Failure | 25.00 (0.0 to 55.0) | 28.57 (0.0 to 62.0) |
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.
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 75.00 (45.0 to 100.0) | 57.14 (20.5 to 93.8) |
| Failure | 25.00 (0.0 to 55.0) | 42.86 (6.2 to 79.5) |
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.
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 75.00 (45.0 to 100.0) | 57.14 (20.5 to 93.8) |
| Failure | 25.00 (0.0 to 55.0) | 42.86 (6.2 to 79.5) |
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).
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 75.00 (45.0 to 100.0) | 85.71 (59.8 to 100.0) |
| Failure | 25.00 (0.0 to 55.0) | 14.29 (0.0 to 40.2) |
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).
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 75.00 (45.0 to 100.0) | 57.14 (20.5 to 93.8) |
| Failure | 25.00 (0.0 to 55.0) | 42.86 (6.2 to 79.5) |
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).
| percentage of participants | Anidulafungin | Fluconazole |
|---|---|---|
| Success | 62.50 (29.0 to 96.0) | 57.14 (20.5 to 93.8) |
| Failure | 37.50 (4.0 to 71.0) | 42.86 (6.2 to 79.5) |
| participants | Anidulafungin | Fluconazole |
|---|---|---|
| Number of Participants Who Died | 1 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anidulafungin | — | 2/9 (22.2%) | 6/9 (66.7%) |
| Fluconazole | — | 0/8 (0%) | 6/8 (75%) |
| Event | Anidulafungin | Fluconazole |
|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/9 | 0/8 |
| Disease progressionGeneral disorders | 1/9 | 0/8 |
| Event | Anidulafungin | Fluconazole |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/9 | 2/8 |
| VomitingGastrointestinal disorders | 1/9 | 2/8 |
| Decreased appetiteMetabolism and nutrition disorders | 0/9 | 2/8 |
| PyrexiaGeneral disorders | 2/9 | 1/8 |
| White blood cell count increasedInvestigations | 2/9 | 0/8 |
| HypoproteinaemiaMetabolism and nutrition disorders | 2/9 | 0/8 |
| NauseaGastrointestinal disorders | 0/9 | 1/8 |
| Chest discomfortGeneral disorders | 0/9 | 1/8 |
| NasopharyngitisInfections and infestations | 0/9 | 1/8 |
| HypokalaemiaMetabolism and nutrition disorders | 1/9 | 1/8 |
| Age, Customized(participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| Between 18 and 44 years | 1 | 4 | 5 |
| Between 45 and 64 years | 4 | 2 | 6 |
| More than 65 years | 4 | 2 | 6 |
| Sex: Female, Male(Participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 8 | 5 | 13 |
| Presence of Signs and Symptoms of Candidemia(participants) | Anidulafungin | Fluconazole | Total |
|---|---|---|---|
| Fever | 7 | 7 | 14 |
| Hypothermia | 0 | 0 | 0 |
| Tachycardia | 3 | 2 | 5 |
| White blood cell count decreased | 2 | 0 | 2 |
| White blood cell count increased | 3 | 1 | 4 |
| White blood cell morphology abnormal | 0 | 1 | 1 |
| Respiratory rate increased | 2 | 1 | 3 |
| Partial pressure of carbon dioxide (PCO2) decrease | 0 | 1 | 1 |
| Mechanical ventilation | 1 | 1 | 2 |
| Swelling | 1 | 2 | 3 |
| Feeling hot | 4 | 4 | 8 |
| Localized erythema | 1 | 0 | 1 |
| Purulence | 1 | 2 | 3 |
| Other | 2 | 1 | 3 |
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer