CandidemiaPhase 3NCT01176058
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
A Phase 3 study testing Anidulafungin/Fluconazole in people with Candidemia, run by Pfizer at 7 sites in China.
Trial summary
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- What is being tested?
- Anidulafungin/Fluconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesChina
- Study dates
- Dec 2010to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of candidemia or invasive candidiasis.
- Presence of one or more of signs and symptoms of acute fungal infection.
Who cannot join
- Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.
- Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking Union Medical College Hospital / Department of Infectious Disease
Beijing, 100730
Nanfang Hospital
Guangzhou, Guangdong, 510515
The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology
Hangzhou, Zhejiang, 310003
Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
Nanjing General Hospital of Nanjing Military Command/Respiratory Department
Nanjing, Jiangsu, 210002
Changhai Hospital, Hemotology Department
Shanghai, Shanghai Municipality, 200433
Institute of Antibiotics, Hua Shan Hospital, Fudan University
Shanghai, 200040
About this study
Official title: A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.
Read the detailed description
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.
- Conditions
- Candidemia
- Being tested
- Anidulafungin/Fluconazole
- Keywords
- Phase 3b, Efficacy and Safety evaluation of Anidulafungin, ICC
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anidulafungin/FluconazoleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| open label | Active comparator | Not described Receives: Drug: Anidulafungin/Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Intravenous Treatment (Up to Day 42)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Post treatment follow-up visit (Up to Day 52)
Number of Participants Who Died
Measured: Baseline to Day 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176058
- Sponsor's protocol ID
- A8851023
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2010
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis
- ClinicalTrials.gov ID
- NCT01176058
- Acronym / sponsor ID
- A8851023
- Conditions
- Candidemia
- Keywords
- Phase 3b, Efficacy and Safety evaluation of Anidulafungin, ICC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Posted 21 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Active comparator | Drug: Anidulafungin/Fluconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of candidemia or invasive candidiasis.
- Presence of one or more of signs and symptoms of acute fungal infection.
Key exclusion criteria (2 listed)
- Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.
- Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anidulafungin/FluconazoleAnidulafungin: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 | Drug | open label |
Primary outcome
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)
Time frame: 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.
8 secondary outcomes
Percentage of Participants With Global Response at End of Treatment (EOT)
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at EOIT
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at EOT
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Clinical Response at Follow-Up
Time frame: Post treatment follow-up visit (Up to Day 52)
Percentage of Participants With Microbiological Response at EOIT
Time frame: End of Intravenous Treatment (Up to Day 42)
Percentage of Participants With Microbiological Response at EOT
Time frame: End of Treatment (Up to Day 42)
Percentage of Participants With Microbiological Response at Follow-Up
Time frame: Post treatment follow-up visit (Up to Day 52)
Number of Participants Who Died
Time frame: Baseline to Day 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Candidemia
RecruitingObservational study
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
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Not yet recruitingObservational study
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Candidemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anidulafungin/Fluconazole in people with Candidemia, run by Pfizer at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT) (time frame: End of Intravenous Treatment (Up to Day 42)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.