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Invasive CandidiasisPhase 3ICENCT00689338

Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

A Phase 3 study testing Anidulafungin, Fluconazole and Voriconazole in people with Invasive Candidiasis, run by Pfizer at 61 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Invasive Candidiasis
What is being tested?
Anidulafungin, Fluconazole and Voriconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
61 sitesin 19 countries
Study dates
Jul 2008to May 2010
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

  • ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
  • Post-abdominal surgery.
  • Elderly > 65 years old.
  • Renal insufficiency / failure / hemodialysis.
  • Solid tumor.
  • Solid-organ (liver, kidney, lung, heart) transplant recipients.
  • Hepatic insufficiency.
  • Neutropenic including hematology oncology patients.

Who cannot join

  • Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

Trial locations and contacts

61 sites in 19 countries.

61 sites in 19 countries

France8 sites

  • Pfizer Investigational Site

    Amiens, France, 80054

  • Pfizer Investigational Site

    Bordeaux, France, 33076

  • Pfizer Investigational Site

    Clichy, France, 92110

  • Pfizer Investigational Site

    Lyon, France, 69433

  • Pfizer Investigational Site

    Marseille, France, 13385

  • Pfizer Investigational Site

    Montpellier, France, 34295

  • Pfizer Investigational Site

    Paris, France, 75877

  • Pfizer Investigational Site

    Villejuif, 94804

Other trials in France

Belgium6 sites

  • Pfizer Investigational Site

    Brussels, 1090

  • Pfizer Investigational Site

    Brussels, B-1070

  • Pfizer Investigational Site

    Ghent, 9000

  • Pfizer Investigational Site

    Leuven, 3000

  • Pfizer Investigational Site

    Liège, B-4000

  • Pfizer Investigational Site

    Yvoir, 5530

Other trials in Belgium

Italy5 sites

  • Pfizer Investigational Site

    Pisa, 56124

  • Pfizer Investigational Site

    Roma, 00161

  • Pfizer Investigational Site

    Roma, 00168

  • Pfizer Investigational Site

    Torino, 10143

  • Pfizer Investigational Site

    Udine, 33100

Other trials in Italy

Russia5 sites

  • Pfizer Investigational Site

    Moscow, 115478

  • Pfizer Investigational Site

    Moscow, 121552

  • Pfizer Investigational Site

    Moscow, 125167

  • Pfizer Investigational Site

    Saint Petersburg, 191015

  • Pfizer Investigational Site

    Saint Petersburg, 194291

Other trials in Russia

Portugal4 sites

  • Pfizer Investigational Site

    Coimbra, 3040-853

  • Pfizer Investigational Site

    Lisbon, 1349-019

  • Pfizer Investigational Site

    Porto, 4200-072

  • Pfizer Investigational Site

    Porto, 4200-319

Other trials in Portugal

Canada3 sites

  • Pfizer Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • Pfizer Investigational Site

    Hamilton, Ontario, L8N 4A6

  • Pfizer Investigational Site

    Québec, Quebec, G1R 2J6

Other trials in Canada

Czechia3 sites

  • Pfizer Investigational Site

    Brno, 656 91

  • Pfizer Investigational Site

    Ostrava, 708 52

  • Pfizer Investigational Site

    Prague, 100 34

Other trials in Czechia

Germany3 sites

  • Pfizer Investigational Site

    Berlin, 10117

  • Pfizer Investigational Site

    Freiburg im Breisgau, 79106

  • Pfizer Investigational Site

    Wuppertal, 42283

Other trials in Germany

Slovakia3 sites

  • Pfizer Investigational Site

    Bratislava, 033 10

  • Pfizer Investigational Site

    Bratislava, 851 07

  • Pfizer Investigational Site

    Košice, 041 66

Other trials in Slovakia

Turkey (Türkiye)3 sites

  • Pfizer Investigational Site

    Ankara, 06100

  • Pfizer Investigational Site

    Görükle, Bursa, 16045

  • Pfizer Investigational Site

    Trabzon, 61080

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Pfizer Investigational Site

    Leeds, West Yorkshire, LS1 3EX

  • Pfizer Investigational Site

    Liverpool, L7 8XP

  • Pfizer Investigational Site

    London, SE5 9RS

Other trials in United Kingdom

Denmark2 sites

  • Pfizer Investigational Site

    Koebenhavn OE, 2100

  • Pfizer Investigational Site

    Odense C, 5000

Other trials in Denmark

Greece2 sites

  • Pfizer Investigational Site

    Haidari, Attica, 12462

  • Pfizer Investigational Site

    Kifissia, Athens, 14561

Other trials in Greece

Hungary2 sites

  • Pfizer Investigational Site

    Budapest, 1106

  • Pfizer Investigational Site

    Budapest, 1125

Other trials in Hungary

Netherlands2 sites

  • Pfizer Investigational Site

    Ede, 6716 RP

  • Pfizer Investigational Site

    Rotterdam, 3083 AN

Other trials in Netherlands

Poland2 sites

  • Pfizer Investigational Site

    Krakow, 31-501

  • Pfizer Investigational Site

    Lodz, 90-153

Other trials in Poland

Romania2 sites

  • Pfizer Investigational Site

    Bucharest, 022328

  • Pfizer Investigational Site

    Iași, Iaşi, 700111

Other trials in Romania

Ukraine2 sites

  • Pfizer Investigational Site

    Dnipropetrovsk, 49600

  • Pfizer Investigational Site

    Donetsk, 84003

Other trials in Ukraine

Austria1 site

  • Pfizer Investigational Site

    Vienna, A-1090

Other trials in Austria

About this study

Official title: Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Being tested
Anidulafungin, Fluconazole, Voriconazole
Keywords
Candida, Candidemia, Systemic Candidiasis, ICU, Intensive Care Unit, Critical Care Unit, Anidulafungin, Ecalta, Eraxis, Fluconazole, Voriconazole
Medical subject headings
Candidiasis, Invasive, Torulopsis, Candidemia, Systemic candidiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnidulafunginDrug

    Anidulafungin Intravenous Administration

  • FluconazoleDrug

    Oral Administration of Fluconazole

  • VoriconazoleDrug

    Oral Administration of Voriconazole

Study groups in NCT00689338
Study groupRoleWhat they receive
Treatment GroupExperimentalOption to treat with oral azole therapy following treatment with anidulafungin
Receives: Drug: Anidulafungin; Drug: Fluconazole; Drug: Voriconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Global Treatment Response Success at End of Treatment

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

    Measured: End of Treatment (Day 14 to Day 56)

Secondary outcomes (6)

  1. Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT)

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

    Measured: EOIVT (Day 10 up to Day 42)

  2. Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

    Measured: 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14)

  3. Percentage of Participants With Global Response Success 6 Weeks After End of Treatment

    Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success).

    Measured: 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42)

  4. Time to First Negative Blood Culture

    Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication.

    Measured: Day 1 up to Day 42

  5. Day 90 Survival

    Percentage of participants known or assumed to be alive on Day 90.

    Measured: Day 90

  6. Time to Successful Intensive Care Unit (ICU) Discharge

    Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT.

    Measured: Day 1 up to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00689338
Sponsor's protocol ID
A8851019
Acronym
ICE
Status last verified
May 2011
First submitted
29 May 2008
Last updated
30 May 2011
Data monitoring committee
No

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 33891293

  • Sganga 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 31280481

  • Kontoyiannis 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 28597967

  • Kullberg 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anidulafungin, Fluconazole and Voriconazole in people with Invasive Candidiasis, run by Pfizer at 61 sites in 19 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in France, Belgium, Italy, Russia, Portugal and 14 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 17 May 2011). 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 Treatment Response Success at End of Treatment (time frame: End of Treatment (Day 14 to Day 56)). 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 NCT00689338, 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 30 May 2011; AzTrials last refreshed its copy on 6 Nov 2026.

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