CandidiasisPhase 3NCT00805740
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida
A Phase 3 study testing Active anidulafungin and Active Caspofungin in people with Candidiasis and Fungemia, run by Pfizer at 18 sites in 9 countries.
Trial summary
The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Candidiasis, Fungemia
- What is being tested?
- Active anidulafungin and Active Caspofungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 18 sitesin 9 countries
- Study dates
- Apr 2009to Jun 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
- Male or female ≥ 16 years of age.
- Expected hospitalization for at least fourteen (14) days.
Who cannot join
- Pregnancy or breast feeding or planning to become pregnant during the study.
- Recent treatment with one of the study drugs over the last 30 days.
- Allergy to either study drug or to this class of drugs.
- Significant liver dysfunction.
- Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
Trial locations and contacts
18 sites in 9 countries.
18 sites in 9 countries
United States4 sites
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Newark, Delaware, 19718
Pfizer Investigational Site
Wilmington, Delaware, 19801
Belgium4 sites
Pfizer Investigational Site
Antwerp, 2060
Pfizer Investigational Site
Brussels, 1000
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Brussels, 1200
Netherlands3 sites
Pfizer Investigational Site
Amsterdam, 1081 HZ
Pfizer Investigational Site
Amsterdam, 1091 AC
Pfizer Investigational Site
Nijmegen, 6532 SZ
Portugal2 sites
Pfizer Investigational Site
Coimbra, 3040-853
Pfizer Investigational Site
Lisbon, 1150-199
Russia1 site
Pfizer Investigational Site
P/o Stepanovskoe, Krasnogorskiy District, Moscow Region, 143423
About this study
Official title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection
The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
- Conditions
- Candidiasis, Fungemia
- Being tested
- Active anidulafungin, Active Caspofungin
- Keywords
- Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection
- Medical subject headings
- Candidiasis, Fungemia, Candidiasis, Invasive, Torulopsis, Candidemia, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active anidulafunginDrug
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Active CaspofunginDrug
Subjects in this arm will receive active caspofungin and placebo anidulafungin
| Study group | Role | What they receive |
|---|---|---|
| Anidulafungin arm | Experimental | Not described Receives: Drug: Active anidulafungin |
| Caspofungin arm | Experimental | Not described Receives: Drug: Active Caspofungin |
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 Treatment (Day 14 To Day 42)
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
Measured: End of Treatment (Day 14 to Day 42)
Secondary outcomes (8)
Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
Measured: 2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Response Based on Clinical Cure and Microbiological Success
A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.
Measured: EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Clinical Response
A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.
Measured: Day 10
Percentage of Participants With Relapse
Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.
Measured: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With New Infection
New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.
Measured: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Time to Negative Blood Culture
Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.
Measured: Baseline up to 6-week follow-up (6 weeks after EOT)
Percentage of Participants With All-cause Mortality
All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.
Measured: Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)
Time to Death
Time to death (days) was assessed as date of death minus first treatment date plus 1.
Measured: Baseline up to 6-week follow-up (6 weeks after EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: The study was terminated prematurely on May 18, 2012 due to slow enrollment. The study was not terminated due to any safety issues or concerns.
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CandidiasisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 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
- NCT00805740
- Sponsor's protocol ID
- A8851022
- Status last verified
- May 2013
- First submitted
- 26 Nov 2008
- Last updated
- 1 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
PubMed 33891293Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
PubMed 31280481Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
PubMed 28597967Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
PubMed 28459966
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection
- ClinicalTrials.gov ID
- NCT00805740
- Acronym / sponsor ID
- A8851022
- Conditions
- Candidiasis, Fungemia
- Keywords
- Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely on May 18, 2012 due to slow enrollment. The study was not terminated due to any safety issues or concerns.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Posted 1 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anidulafungin arm | Experimental | Drug: Active anidulafungin |
| Caspofungin arm | Experimental | Drug: Active Caspofungin |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
- Male or female ≥ 16 years of age.
- Expected hospitalization for at least fourteen (14) days.
Key exclusion criteria (5 listed)
- Pregnancy or breast feeding or planning to become pregnant during the study.
- Recent treatment with one of the study drugs over the last 30 days.
- Allergy to either study drug or to this class of drugs.
- Significant liver dysfunction.
- Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
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 |
|---|---|---|
| Active anidulafunginSubjects in this arm will receive active anidulafungin and placebo caspofungin | Drug | Anidulafungin arm |
| Active CaspofunginSubjects in this arm will receive active caspofungin and placebo anidulafungin | Drug | Caspofungin arm |
Primary outcome
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)
Time frame: End of Treatment (Day 14 to Day 42)
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
8 secondary outcomes
Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit
Time frame: 2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Response Based on Clinical Cure and Microbiological Success
Time frame: EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Clinical Response
Time frame: Day 10
Percentage of Participants With Relapse
Time frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With New Infection
Time frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Time to Negative Blood Culture
Time frame: Baseline up to 6-week follow-up (6 weeks after EOT)
Percentage of Participants With All-cause Mortality
Time frame: Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)
Time to Death
Time frame: Baseline up to 6-week follow-up (6 weeks after EOT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33891293De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
- Derived from this study: PubMed 31280481Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
- Derived from this study: PubMed 28597967Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
- Derived from this study: PubMed 28459966Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
18 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active anidulafungin and Active Caspofungin in people with Candidiasis and Fungemia, run by Pfizer at 18 sites in 9 countries.
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 3 inclusion and 5 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 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Belgium, Netherlands, Portugal, Bulgaria and 4 more countries. 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 1 Aug 2013). 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 Treatment (Day 14 To Day 42) (time frame: End of Treatment (Day 14 to Day 42)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805740, which also lists 4 linked publications.
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 1 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.