Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

NCT00106288 | Completed Phase 3 DMC

• 1 other identifier: FG-463-21-08
• Study Type: interventional
• Target: 637
• Locations: 2 countries
• Sites: 37

Brief 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.

Conditions

Candidiasis

Keywords

Candidaemia; Micafungin

Outcome Measures

Primary Outcomes (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.

  6 and 12 weeks post treatment

Secondary Outcomes (8)

• 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

  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

Study Arms (2)

1

EXPERIMENTAL

Drug: Micafungin

2

ACTIVE COMPARATOR

Drug: Liposomal Amphotericin B

Interventions

Micafungin DRUG

IV

Also known as: Mycamine, FK463

1

Liposomal Amphotericin B DRUG

IV

Also known as: AmBisome

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (37)

Unknown Facility

Birmingham, Alabama, 35294-0006, United States

Location

Unknown Facility

Orange, California, 92868, United States

Location

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

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

Location

Unknown Facility

Jacksonville, Florida, 32207, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Hinsdale, Illinois, 60521, United States

Location

Unknown Facility

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Lexington, Kentucky, 40536-0084, United States

Location

Unknown Facility

Baltimore, Maryland, 21201-1595, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Boston, Massachusetts, 02211, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Rochester, New York, 14642, United States

Location

Unknown Facility

Valhalla, New York, 10595, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19140, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78229-3900, United States

Location

Unknown Facility

Provo, Utah, 84604, United States

Location

Unknown Facility

Calgary, Alberta, T2N 2T9, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Unknown Facility

Hamilton, Ontario, L8V 1C3, Canada

Location

Unknown Facility

Toronto, Ontario, M5S 2N9, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 2M4, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 4M1, Canada

Location

Unknown Facility

Québec, Quebec, G1R 2J6, Canada

Location

Unknown Facility

Regina, Saskatchewan, S4P OW5, Canada

Location

Related Publications (5)

• 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.

  PMID: 17482982 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.

  PMID: 18679151 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.

  PMID: 20013016 BACKGROUND

• 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.

  PMID: 21147825 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.

  PMID: 19804626 DERIVED

MeSH Terms

Conditions

Candidiasis; Candidemia

Interventions

Micafungin; liposomal amphotericin B

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Candidiasis, Invasive; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2005
• First Posted: March 23, 2005
• Study Start: January 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (27); CA (10)