Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
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ClinicalTrials.gov Identifier: NCT00106288 |
Recruitment Status
:
Completed
First Posted
: March 23, 2005
Last Update Posted
: September 18, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Candidiasis | Drug: Micafungin Drug: Liposomal Amphotericin B | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 637 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | December 2005 |
Actual Study Completion Date : | December 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Micafungin
IV
Other Names:
|
Active Comparator: 2 |
Drug: Liposomal Amphotericin B
IV
Other Name: AmBisome
|
- 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 ]
- Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period [ Time Frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period ]
- Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period [ Time Frame: During the 2 to 8 week treatment period and the 12 week post treatment followup period ]
- Overall incidence of emergent and recurrent fungal infections at the End of Study [ Time Frame: End of the 12 week post treatment followup peroid ]
- Independent Efficacy Review Committee's assessment of overall treatment success [ Time Frame: Prior to database lock ]
- Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline [ Time Frame: During the 2 to 8 week treatment period ]
- Incidence of acute infusion related reactions as pre-defined [ Time Frame: During the 2 to 8 week treatment period ]
- Patient survival at the End of Therapy and at the End of Study [ Time Frame: End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period ]
- Overall incidence of Adverse Events (AE) [ Time Frame: Throughout study and post treatment followup period ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106288

United States, Alabama | |
Birmingham, Alabama, United States, 35294-0006 | |
United States, California | |
Orange, California, United States, 92868 | |
United States, Colorado | |
Denver, Colorado, United States, 80218 | |
United States, District of Columbia | |
Washington, DC, District of Columbia, United States, 20010-2970 | |
United States, Florida | |
Jacksonville, Florida, United States, 32207 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Hinsdale, Illinois, United States, 60521 | |
Maywood, Illinois, United States, 60153 | |
United States, Kansas | |
Kansas City, Kansas, United States, 66160 | |
United States, Kentucky | |
Lexington, Kentucky, United States, 40536-0084 | |
United States, Maryland | |
Baltimore, Maryland, United States, 21201-1595 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02115 | |
Boston, Massachusetts, United States, 02211 | |
United States, Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
New York, New York, United States, 10021 | |
New York, New York, United States, 10029 | |
New York, New York, United States, 10032 | |
Rochester, New York, United States, 14642 | |
Valhalla, New York, United States, 10595 | |
United States, North Carolina | |
Durham, North Carolina, United States, 27710 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Philadelphia, Pennsylvania, United States, 19107 | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
San Antonio, Texas, United States, 78229-3900 | |
United States, Utah | |
Provo, Utah, United States, 84604 | |
Canada, Alberta | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Canada, Manitoba | |
Winnipeg, Manitoba, Canada, R3A 1R9 | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Canada, Ontario | |
Hamilton, Ontario, Canada, L8V 1C3 | |
Toronto, Ontario, Canada, M5S 2N9 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H1T 2M4 | |
Montreal, Quebec, Canada, H2L 4M1 | |
Canada, Saskatchewan | |
Regina, Saskatchewan, Canada, S4P OW5 | |
Canada | |
Quebec, Canada, G1R 2J6 |
Study Chair: | Use Central Contact | Astellas Pharma Europe B.V. |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00106288 History of Changes |
Other Study ID Numbers: |
FG-463-21-08 |
First Posted: | March 23, 2005 Key Record Dates |
Last Update Posted: | September 18, 2014 |
Last Verified: | September 2014 |
Keywords provided by Astellas Pharma Inc:
Candidaemia Micafungin |
Additional relevant MeSH terms:
Candidiasis Candidemia Candidiasis, Invasive Mycoses Fungemia Sepsis Infection Invasive Fungal Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Amphotericin B Liposomal amphotericin B Micafungin Echinocandins Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Anti-Bacterial Agents Antifungal Agents |