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Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Primary Purpose

Candidiasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Micafungin
Liposomal Amphotericin B
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Candidaemia, Micafungin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period
Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period
Overall incidence of emergent and recurrent fungal infections at the End of Study
Independent Efficacy Review Committee's assessment of overall treatment success
Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline
Incidence of acute infusion related reactions as pre-defined
Patient survival at the End of Therapy and at the End of Study
Overall incidence of Adverse Events (AE)

Full Information

First Posted
March 22, 2005
Last Updated
September 17, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00106288
Brief Title
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
Keywords
Candidaemia, Micafungin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
637 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
Mycamine, FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Liposomal Amphotericin B
Other Intervention Name(s)
AmBisome
Intervention Description
IV
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Overall incidence of emergent and recurrent fungal infections at the End of Study
Time Frame
End of the 12 week post treatment followup peroid
Title
Independent Efficacy Review Committee's assessment of overall treatment success
Time Frame
Prior to database lock
Title
Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline
Time Frame
During the 2 to 8 week treatment period
Title
Incidence of acute infusion related reactions as pre-defined
Time Frame
During the 2 to 8 week treatment period
Title
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
Title
Overall incidence of Adverse Events (AE)
Time Frame
Throughout study and post treatment followup period

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Washington, DC
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02211
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2N9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P OW5
Country
Canada
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17482982
Citation
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.
Results Reference
background
PubMed Identifier
18679151
Citation
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.
Results Reference
background
PubMed Identifier
20013016
Citation
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.
Results Reference
background
PubMed Identifier
21147825
Citation
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.
Results Reference
derived
PubMed Identifier
19804626
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140598 in the JapicCTI-RNo. field

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Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

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