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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 and 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period | 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 |
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Inclusion Criteria:
Patients either non-neutropenic with absolute neutrophil counts >= 500 cells/mm3 or neutropenic with absolute neutrophil counts < 500 cells/mm3 must have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-0006 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17482982 | Background | 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. | |
| 18679151 |
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| Liposomal Amphotericin B |
| Drug |
IV |
|
|
| 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 | End of the 12 week post treatment followup peroid |
| Independent Efficacy Review Committee's assessment of overall treatment success | Prior to database lock |
| Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline | During the 2 to 8 week treatment period |
| Incidence of acute infusion related reactions as pre-defined | During the 2 to 8 week treatment period |
| Patient survival at the End of Therapy and at the End of Study | 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) | Throughout study and post treatment followup period |
| Orange |
| California |
| 92868 |
| United States |
| Denver | Colorado | 80218 | United States |
| Washington D.C. | District of Columbia | 20010-2970 | United States |
| Jacksonville | Florida | 32207 | United States |
| Atlanta | Georgia | 30322 | United States |
| Hinsdale | Illinois | 60521 | United States |
| Maywood | Illinois | 60153 | United States |
| Kansas City | Kansas | 66160 | United States |
| Lexington | Kentucky | 40536-0084 | United States |
| Baltimore | Maryland | 21201-1595 | United States |
| Boston | Massachusetts | 02115 | United States |
| Boston | Massachusetts | 02211 | United States |
| Detroit | Michigan | 48201 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| New York | New York | 10021 | United States |
| New York | New York | 10029 | United States |
| New York | New York | 10032 | United States |
| Rochester | New York | 14642 | United States |
| Valhalla | New York | 10595 | United States |
| Durham | North Carolina | 27710 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229-3900 | United States |
| Provo | Utah | 84604 | United States |
| Calgary | Alberta | T2N 2T9 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Hamilton | Ontario | L8V 1C3 | Canada |
| Toronto | Ontario | M5S 2N9 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Regina | Saskatchewan | S4P OW5 | Canada |
| Background |
| 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. |
| 20013016 | Background | 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. |
| 21147825 | Derived | 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. |
| 19804626 | Derived | 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. |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D058387 | Candidemia |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D058365 | Candidiasis, Invasive |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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