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CandidiasisPhase 3NCT00106288

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

A Phase 3 study testing Micafungin and Liposomal Amphotericin B in people with Candidiasis, run by Astellas Pharma Inc at 37 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Candidiasis
What is being tested?
Micafungin and Liposomal Amphotericin B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
637 participants
Where
37 sitesin 2 countries
Study dates
Jan 2003to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients either non-neutropenic with absolute neutrophil counts >= 500 cells/mm3 or neutropenic with absolute neutrophil counts < 500 cells/mm3 must have:
  • Candidemia or invasive candidiasis,
  • Confirmation and typical clinical signs and symptoms by fungal culture and/or histology,
  • Positive culture obtained no more than four days prior to the first dose of study medication.

Who cannot join

  • Patient is pregnant or nursing
  • Patients with evidence of liver disease as defined by: a) SGOT/AST or SGPT/ALT > 10 times the upper limit of normal (ULN); or b) Total bilirubin > 5 times ULN.
  • Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains.
  • Patients who have received prophylactic/empiric therapy with azoles or conventional amphotericin B for more than three days within one week prior to enrollment. Neutropenic patients, however, may have received prophylactic azoles without time restrictions.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States27 sites

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21201-1595

  • Study site

    Birmingham, Alabama, 35294-0006

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02211

  • Study site

    Denver, Colorado, 80218

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Hinsdale, Illinois, 60521

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Lexington, Kentucky, 40536-0084

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Orange, California, 92868

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Provo, Utah, 84604

  • Study site

    Rochester, New York, 14642

  • Study site

    San Antonio, Texas, 78229-3900

  • Study site

    Valhalla, New York, 10595

  • Study site

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

Canada10 sites

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Hamilton, Ontario, L8V 1C3

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Québec, Quebec, G1R 2J6

  • Study site

    Regina, Saskatchewan, S4P OW5

  • Study site

    Toronto, Ontario, M5S 2N9

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: A Multicenter, Double Blind, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Micafungin (FK463) Versus Liposomal Amphotericin B (AmBisome) in the Treatment of Invasive Candidiasis and Candidemia

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

Read the detailed description

A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.

Conditions
Candidiasis
Being tested
Micafungin, Liposomal Amphotericin B
Keywords
Candidaemia, Micafungin
Medical subject headings
Candidiasis, Candidemia

What participants receive

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

  • MicafunginDrug

    Also called Mycamine, FK463

    IV

  • Liposomal Amphotericin BDrug

    Also called AmBisome

    IV

Study groups in NCT00106288
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Micafungin
2Active comparatorNot described
Receives: Drug: Liposomal Amphotericin B

What is being measured

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

  1. Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.

    Measured: 6 and 12 weeks post treatment

Secondary outcomes (8)

  1. Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period

    Measured: During the 2 to 8 week treatment period and the 12 week post treatment followup period

  2. Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period

    Measured: During the 2 to 8 week treatment period and the 12 week post treatment followup period

  3. Overall incidence of emergent and recurrent fungal infections at the End of Study

    Measured: End of the 12 week post treatment followup peroid

  4. Independent Efficacy Review Committee's assessment of overall treatment success

    Measured: Prior to database lock

  5. Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline

    Measured: During the 2 to 8 week treatment period

  6. Incidence of acute infusion related reactions as pre-defined

    Measured: During the 2 to 8 week treatment period

  7. Patient survival at the End of Therapy and at the End of Study

    Measured: End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period

  8. Overall incidence of Adverse Events (AE)

    Measured: Throughout study and post treatment followup period

Timeline

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

  1. First posted23 Mar 2005 (estimated)
  2. Study startJan 2003
  3. Primary completionDec 2005
  4. Study completionDec 2005

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106288
Sponsor's protocol ID
FG-463-21-08
Status last verified
Sep 2014
First submitted
22 Mar 2005
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Kuse ER, Chetchotisakd P, da Cunha CA, Ruhnke M, Barrios C, Raghunadharao D, Sekhon JS, Freire A, Ramasubramanian V, Demeyer I, Nucci M, Leelarasamee A, Jacobs F, Decruyenaere J, Pittet D, Ullmann AJ, Ostrosky-Zeichner L, Lortholary O, Koblinger S, Diekmann-Berndt H, Cornely OA; Micafungin Invasive Candidiasis Working Group. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. Lancet. 2007 May 5;369(9572):1519-1527. doi: 10.1016/S0140-6736(07)60605-9.

    PubMed 17482982

  • Queiroz-Telles F, Berezin E, Leverger G, Freire A, van der Vyver A, Chotpitayasunondh T, Konja J, Diekmann-Berndt H, Koblinger S, Groll AH, Arrieta A; Micafungin Invasive Candidiasis Study Group. Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. Pediatr Infect Dis J. 2008 Sep;27(9):820-6. doi: 10.1097/INF.0b013e31817275e6.

    PubMed 18679151

  • Horn DL, Ostrosky-Zeichner L, Morris MI, Ullmann AJ, Wu C, Buell DN, Kovanda LL, Cornely OA. Factors related to survival and treatment success in invasive candidiasis or candidemia: a pooled analysis of two large, prospective, micafungin trials. Eur J Clin Microbiol Infect Dis. 2010 Feb;29(2):223-9. doi: 10.1007/s10096-009-0843-0. Epub 2009 Dec 15.

    PubMed 20013016

  • Shorr AF, Wu C, Kothari S. Outcomes with micafungin in patients with candidaemia or invasive candidiasis due to Candida glabrata and Candida krusei. J Antimicrob Chemother. 2011 Feb;66(2):375-80. doi: 10.1093/jac/dkq446. Epub 2010 Dec 8.

    PubMed 21147825

  • Dupont BF, Lortholary O, Ostrosky-Zeichner L, Stucker F, Yeldandi V. Treatment of candidemia and invasive candidiasis in the intensive care unit: post hoc analysis of a randomized, controlled trial comparing micafungin and liposomal amphotericin B. Crit Care. 2009;13(5):R159. doi: 10.1186/cc8117. Epub 2009 Oct 5.

    PubMed 19804626

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Micafungin and Liposomal Amphotericin B in people with Candidiasis, run by Astellas Pharma Inc at 37 sites in 2 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 4 inclusion and 4 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 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy. (time frame: 6 and 12 weeks post treatment). 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 NCT00106288, which also lists 5 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 18 Sep 2014.

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